HANSON MEDICAL FACIAL IMPLANTS

Prosthesis, Nose, Internal

HANSON MEDICAL, INC.

The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Hanson Medical Facial Implants.

Pre-market Notification Details

• Device ID: K090803
• 510k Number: K090803
• Device Name: HANSON MEDICAL FACIAL IMPLANTS
• Classification: Prosthesis, Nose, Internal
• Applicant: HANSON MEDICAL, INC. 2706 WASH BLVD. P.O. BOX 1160 Kingston, WA 98346
• Contact: Gerald Hanson
• Correspondent: Gerald Hanson; HANSON MEDICAL, INC. 2706 WASH BLVD. P.O. BOX 1160 Kingston, WA 98346
• Product Code: FZE
• CFR Regulation Number: 878.3680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-24
• Decision Date: 2010-06-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B049SCH440	K090803	000
B049SCH730	K090803	000
B049SCH810	K090803	000
B049SCH820	K090803	000
B049SCH830	K090803	000
B049SCH840	K090803	000
B049SM1010	K090803	000
B049SM110	K090803	000
B049SM1110	K090803	000
B049SCH720	K090803	000
B049SCH710	K090803	000
B049SCH510	K090803	000
B049SCH520	K090803	000
B049SCH530	K090803	000
B049SCH540	K090803	000
B049SCH550	K090803	000
B049SCH610	K090803	000
B049SCH620	K090803	000
B049SCH630	K090803	000
B049SM1120	K090803	000
B049SM1130	K090803	000
B049SM1140	K090803	000
B049SM310	K090803	000
B049SM320	K090803	000
B049SM410	K090803	000
B049SM420	K090803	000
B049SM430	K090803	000
B049SM440	K090803	000
B049SM510	K090803	000
B049SM520	K090803	000
B049SM240	K090803	000
B049SM230	K090803	000
B049SM120	K090803	000
B049SM1210	K090803	000
B049SM1220	K090803	000
B049SM1230	K090803	000
B049SM1240	K090803	000
B049SM130	K090803	000
B049SM210	K090803	000
B049SM220	K090803	000
B049SM530	K090803	000
B049SCH1010	K090803	000
B049SCH1230	K090803	000
B049SCH1240	K090803	000
B049SCH130	K090803	000
B049SCH1310	K090803	000
B049SCH1320	K090803	000
B049SCH1330	K090803	000
B049SCH1340	K090803	000
B049SCH140	K090803	000
B049SCH1220	K090803	000
B049SCH1210	K090803	000
B049SCH1020	K090803	000
B049SCH1030	K090803	000
B049SCH1040	K090803	000
B049SCH110	K090803	000
B049SCH1110	K090803	000
B049SCH1120	K090803	000
B049SCH1130	K090803	000
B049SCH120	K090803	000
B049SCH1410	K090803	000
B049SCH1420	K090803	000
B049SCH1430	K090803	000
B049SCH230	K090803	000
B049SCH240	K090803	000
B049SCH310	K090803	000
B049SCH320	K090803	000
B049SCH330	K090803	000
B049SCH340	K090803	000
B049SCH410	K090803	000
B049SCH420	K090803	000
B049SCH220	K090803	000
B049SCH2170	K090803	000
B049SCH1440	K090803	000
B049SCH1510	K090803	000
B049SCH1520	K090803	000
B049SCH1530	K090803	000
B049SCH1540	K090803	000
B049SCH160	K090803	000
B049SCH170	K090803	000
B049SCH210	K090803	000
B049SCH430	K090803	000
B049SM610	K090803	000
B049SN2W0	K090803	000
B049SN72F0	K090803	000
B049SN72W0	K090803	000
B049SN8F0	K090803	000
B049SN8W0	K090803	000
B049SN9F0	K090803	000
B049SN9W0	K090803	000
B049SND11F0	K090803	000
B049SND12F0	K090803	000
B049SN71W0	K090803	000
B049SN71F0	K090803	000
B049SN3F0	K090803	000
B049SN3W0	K090803	000
B049SN4F0	K090803	000
B049SN4W0	K090803	000
B049SN5F0	K090803	000
B049SN5W0	K090803	000
B049SN6F0	K090803	000
B049SN6W0	K090803	000
B049SND13F0	K090803	000
B049SND14F0	K090803	000
B049SV1F0	K090803	000
B049SVCH1F0	K090803	000
B049SVCH20	K090803	000
B049SVCH2F0	K090803	000
B049SVCH30	K090803	000
B049SVCH3F0	K090803	000
B049SVCH40	K090803	000
B049SVCH4F0	K090803	000
B049SVCH50	K090803	000
B049SVCH10	K090803	000
B049SV5W0	K090803	000
B049SV1W0	K090803	000
B049SV2F0	K090803	000
B049SV2W0	K090803	000
B049SV3F0	K090803	000
B049SV3W0	K090803	000
B049SV4F0	K090803	000
B049SV4W0	K090803	000
B049SV5F0	K090803	000
B049SVCH5F0	K090803	000
B049SM620	K090803	000
B049SM930	K090803	000
B049SN101F0	K090803	000
B049SN101W0	K090803	000
B049SN102F0	K090803	000
B049SN102W0	K090803	000
B049SN11F0	K090803	000
B049SN11W0	K090803	000
B049SN121F0	K090803	000
B049SM920	K090803	000
B049SM910	K090803	000
B049SM630	K090803	000
B049SM710	K090803	000
B049SM720	K090803	000
B049SM730	K090803	000
B049SM740	K090803	000
B049SM810	K090803	000
B049SM820	K090803	000
B049SM830	K090803	000
B049SN121W0	K090803	000
B049SN122F0	K090803	000
B049SN122W0	K090803	000
B049SN151F0	K090803	000
B049SN151W0	K090803	000
B049SN152F0	K090803	000
B049SN152W0	K090803	000
B049SN16F0	K090803	000
B049SN16W0	K090803	000
B049SN1F0	K090803	000
B049SN1W0	K090803	000
B049SN14W0	K090803	000
B049SN14F0	K090803	000
B049SN131F0	K090803	000
B049SN132F0	K090803	000
B049SN133F0	K090803	000
B049SN134F0	K090803	000
B049SN135F0	K090803	000
B049SN136F0	K090803	000
B049SN137F0	K090803	000
B049SN138F0	K090803	000
B049SN2F0	K090803	000