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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K920808
Device Name OB/GYN DRAPE
Applicant
Preferred Medical Products
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Preferred Medical Products
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/21/1992
Decision Date 02/19/1993
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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