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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 K923600
Device Name ENDO OPTIKS VALUE PACK
Applicant
Endo Optics, Inc.
C/O Knopf Associates, Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
Endo Optics, Inc.
C/O Knopf Associates, Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number878.4370
Classification Product Code
LRO  
Date Received07/20/1992
Decision Date 03/23/1993
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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