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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 K936255
Device Name CUSTOM CV PACK
Applicant
Associated Medical
11140 Bren Rd., W.
Minnetonka,  MN  55343
Applicant Contact SCOTT WIEST
Correspondent
Associated Medical
11140 Bren Rd., W.
Minnetonka,  MN  55343
Correspondent Contact SCOTT WIEST
Regulation Number878.4800
Classification Product Code
KDD  
Date Received12/30/1993
Decision Date 03/31/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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