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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K912803
Device Name MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL
Applicant
Medical Sterilization, Inc.
225 Underhill Blvd.
Syosset,  NY  11791
Applicant Contact MICHAEL G.FOGARTY
Correspondent
Medical Sterilization, Inc.
225 Underhill Blvd.
Syosset,  NY  11791
Correspondent Contact MICHAEL G.FOGARTY
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/25/1991
Decision Date 01/10/1992
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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