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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K932219
Device Name SUTURE SET OR LACERATION TRAYS (PACKS)
Applicant
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Applicant Contact SCOTT WEISS
Correspondent
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Correspondent Contact SCOTT WEISS
Regulation Number878.4800
Classification Product Code
KDD  
Subsequent Product Code
FMF  
Date Received05/07/1993
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
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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