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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, rectal
510(k) Number K941391
Device Name INFLATABLE RETENTION CUFF SPECULUM
Applicant
INNOVATEC MEDICAL CORP.
4809 RIVERVIEW WAY
DULUTH,  GA  30097
Applicant Contact ROY ABELL
Correspondent
INNOVATEC MEDICAL CORP.
4809 RIVERVIEW WAY
DULUTH,  GA  30097
Correspondent Contact ROY ABELL
Regulation Number876.5980
Classification Product Code
GBT  
Subsequent Product Code
KPL  
Date Received03/22/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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