FDA 510(k) Application Details - K953355

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K953355
Device Name Forceps, Biopsy, Electric
Applicant MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE, AZ 85283 US
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Contact GINA M GALLEGOS
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 07/17/1995
Decision Date 04/04/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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