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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 K922949
Device Name SURGICAL GOWN
Applicant
Robert J. Sislian, Inc.
739 Ramsey Ave.
Hillside,  NJ  07205
Applicant Contact ROBERT J SISLIAN
Correspondent
Robert J. Sislian, Inc.
739 Ramsey Ave.
Hillside,  NJ  07205
Correspondent Contact ROBERT J SISLIAN
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/18/1992
Decision Date 02/16/1993
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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