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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K931886
Device Name TISSUE ISOLATION AND RETRIEVAL BAG
Applicant
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact ANGELIQUE ANDERSON
Correspondent
Advanced Surgical, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact ANGELIQUE ANDERSON
Regulation Number880.5240
Classification Product Code
KGX  
Date Received04/15/1993
Decision Date 09/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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