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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K913500
Device Name CHERRY SPONGE
Applicant
O.R. Concepts, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
O.R. Concepts, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/07/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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