FDA 510(k) Application Details - K972856

Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

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510(K) Number K972856
Device Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant ROCKET MEDICAL PLC
TYNE & WEAR
WASHINGTON NE37 1NE GB
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Contact L. TODD
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Regulation Number 884.4160

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Classification Product Code KNF
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Date Received 08/01/1997
Decision Date 02/11/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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