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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Battery-Powered And Accessories
510(k) Number K933371
Device Name IMC ENDOSCOPIC INSTRUMENT HOLDER
Applicant
INMAN MEDICAL CORP.
6316 AIRPORT FREEWAY
FORT WORTH,  TX  76117
Applicant Contact JOHN MAYALL
Correspondent
INMAN MEDICAL CORP.
6316 AIRPORT FREEWAY
FORT WORTH,  TX  76117
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
GCS  
Date Received07/09/1993
Decision Date 08/06/1993
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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