DURALASTIC ANATOMICAL CHIN IMPLANTS

Prosthesis, Chin, Internal

HANSON MEDICAL, INC.

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

Pre-market Notification Details

• Device ID: K973575
• 510k Number: K973575
• Device Name: DURALASTIC ANATOMICAL CHIN IMPLANTS
• Classification: Prosthesis, Chin, Internal
• Applicant: HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346
• Contact: Erik Hanson
• Correspondent: Erik Hanson; HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346
• Product Code: FWP
• CFR Regulation Number: 878.3550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-19
• Decision Date: 1997-11-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B049CH22S0	K973575	000
B049CH1510	K973575	000
B049CH14S0	K973575	000
B049CH144S0	K973575	000
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B049CH830	K973575	000
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B049VCH40	K973575	000
B049VCH3S0	K973575	000
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B049VCH2S0	K973575	000
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B049VCH20	K973575	000
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B049CH610	K973575	000
B049CH55S0	K973575	000
B049CH550	K973575	000
B049CH54S0	K973575	000
B049CH540	K973575	000
B049CH53S0	K973575	000
B049CH530	K973575	000
B049CH52S0	K973575	000
B049CH520	K973575	000
B049CH51S0	K973575	000
B049CH510	K973575	000
B049CH44S0	K973575	000
B049CH440	K973575	000
B049CH23S0	K973575	000