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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Endoscope
510(k) Number K915762
Device Name POOLE TIP SUCTION PROBE
Applicant
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
GCI  
Date Received12/24/1991
Decision Date 03/13/1992
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
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