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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K903358
Device Name ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
Applicant
ADVANCE MEDICAL DESIGNS, INC.
808 PICKENS INDUSTRIAL DR.
MARIETTA,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
ADVANCE MEDICAL DESIGNS, INC.
808 PICKENS INDUSTRIAL DR.
MARIETTA,  GA  30062
Correspondent Contact RONALD D ARKIN
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/26/1990
Decision Date 11/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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