ADVANCE MEDICAL DESIGNS FLUID POUCH

Drape, Surgical

ADVANCE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Medical Designs Fluid Pouch.

Pre-market Notification Details

• Device ID: K012168
• 510k Number: K012168
• Device Name: ADVANCE MEDICAL DESIGNS FLUID POUCH
• Classification: Drape, Surgical
• Applicant: ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066
• Contact: Bill Gill
• Correspondent: Bill Gill; ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066
• Product Code: KKX
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-12
• Decision Date: 2001-09-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10848340020336	K012168	000
10848340005791	K012168	000
10848340006323	K012168	000
10848340008570	K012168	000
10848340008853	K012168	000
10848340008860	K012168	000
10848340008877	K012168	000
10848340008884	K012168	000
10848340008891	K012168	000
10848340008907	K012168	000
10848340008914	K012168	000
10848340008938	K012168	000
10848340002165	K012168	000
10848340002158	K012168	000
10848340002141	K012168	000
10848340020343	K012168	000
10848340016599	K012168	000
10848340016605	K012168	000
10848340013963	K012168	000
10848340010023	K012168	000
10848340010788	K012168	000
10848340002097	K012168	000
10848340002103	K012168	000
10848340002110	K012168	000
10848340002127	K012168	000
10848340002134	K012168	000
10848340009041	K012168	000
10848340009072	K012168	000
10848340009089	K012168	000
10848340009409	K012168	000
10848340009416	K012168	000
10848340009423	K012168	000
10848340009430	K012168	000
10848340009478	K012168	000
10848340009485	K012168	000
10848340009492	K012168	000
10848340009508	K012168	000
10848340010740	K012168	000
10848340010757	K012168	000
10848340010764	K012168	000
10848340009379	K012168	000
10848340009294	K012168	000
10848340009287	K012168	000
10848340009096	K012168	000
10848340009102	K012168	000
10848340009119	K012168	000
10848340009126	K012168	000
10848340009133	K012168	000
10848340009140	K012168	000
10848340009157	K012168	000
10848340009164	K012168	000
10848340009171	K012168	000
10848340009188	K012168	000
10848340009195	K012168	000
10848340010771	K012168	000