FDA 510(k) Application Details - K971123

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

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510(K) Number K971123
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant PHX TECHNOLOGIES CORP.
1032 SHADY OAKS DR., NO. 100
DENTON, TX 76205 US
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Contact JAMES F CHAPEL
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 03/27/1997
Decision Date 06/27/1997
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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