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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K903908
Device Name REPAK SURGICAL PACKS
Applicant
Repack Surgical Enterprises, Inc.
One Knollcrest Dr.
P.O. Box 37890
Cincinnati,  OH  45222
Applicant Contact BARBARA STANEWICK
Correspondent
Repack Surgical Enterprises, Inc.
One Knollcrest Dr.
P.O. Box 37890
Cincinnati,  OH  45222
Correspondent Contact BARBARA STANEWICK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/23/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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