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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Microscope, Ophthalmic
510(k) Number K902763
Device Name STERILE INSTRUMENT DRAPE
Applicant
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Applicant Contact HARRY A SCHLAKMAN
Correspondent
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number878.4370
Classification Product Code
HMW  
Date Received06/25/1990
Decision Date 09/20/1990
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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