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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 K984422
Device Name STERILE BACK SURGICAL GOWN WITH HAND TOWEL
Applicant
MEDICAL STERILIZATION, INC.
225 UNDERHILL BLVD.
SYOSSET,  NY  11791
Applicant Contact DAVID MORGANSTERN
Correspondent
MEDICAL STERILIZATION, INC.
225 UNDERHILL BLVD.
SYOSSET,  NY  11791
Correspondent Contact DAVID MORGANSTERN
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/10/1998
Decision Date 04/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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