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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 K931417
Device Name STERILE EQUIPMENT COVERS
Applicant
CUSTOM MEDICAL PRODUCTS, LTD.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
CUSTOM MEDICAL PRODUCTS, LTD.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number878.4370
Classification Product Code
MMP  
Date Received03/22/1993
Decision Date 07/06/1995
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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