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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, single patient use, portable, nonpowered
510(k) Number K923908
Device Name # 9455 AND #9457 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 Number878.4680
Classification Product Code
GCY  
Date Received08/04/1992
Decision Date 05/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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