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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K880942
Device Name REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)
Applicant
Repack Surgical Enterprises, Inc.
One Knollcrest Dr.
P.O. Box 37890
Cincinnati,  OH  45222
Applicant Contact ROB LOWENSTEIN
Correspondent
Repack Surgical Enterprises, Inc.
One Knollcrest Dr.
P.O. Box 37890
Cincinnati,  OH  45222
Correspondent Contact ROB LOWENSTEIN
Regulation Number878.4370
Classification Product Code
LRO  
Date Received03/07/1988
Decision Date 03/21/1988
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
Predetermined Change
Control Plan Authorized		 No
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