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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K943078
Device Name HOT BIOPSY FORCEPS
Applicant
Intl. Medical, Inc.
10061 Amberwood Rd.
Fort Myers,  FL  33913
Applicant Contact PETTER H WETTERMAN
Correspondent
Intl. Medical, Inc.
10061 Amberwood Rd.
Fort Myers,  FL  33913
Correspondent Contact PETTER H WETTERMAN
Regulation Number876.4300
Classification Product Code
KGE  
Date Received06/28/1994
Decision Date 11/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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