FDA 510(k) Application Details - K973259

Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered

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510(K) Number K973259
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant MEDICAL CREATIVE TECHNOLOGIES, INC.
2950-N ADVANCE LN.
COLMAR, PA 18915-9727 US
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Contact PERK CROOK
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 08/29/1997
Decision Date 09/10/1997
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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