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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carrier, Sponge, Endoscopic
510(k) Number K933604
Device Name QB II BLUNT DISSECTOR
Applicant
Joyce M. Shotwell, M.D.
P.O. Box 743007
Dallas,  TX  75374
Applicant Contact JOYCE M SHOTWELL
Correspondent
Joyce M. Shotwell, M.D.
P.O. Box 743007
Dallas,  TX  75374
Correspondent Contact JOYCE M SHOTWELL
Regulation Number876.1500
Classification Product Code
FGS  
Date Received07/27/1993
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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