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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K930552
Device Name STERILE BARRIER SLEEVE AND COVER
Applicant
Patient Safety Products, Inc.
1185 Dean St.
Brooklyn,  NY  11216
Applicant Contact EDMUND BURTON
Correspondent
Patient Safety Products, Inc.
1185 Dean St.
Brooklyn,  NY  11216
Correspondent Contact EDMUND BURTON
Regulation Number878.4370
Classification Product Code
MMP  
Date Received02/03/1993
Decision Date 07/05/1994
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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