FDA 510(k) Application Details - K002042

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K002042
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant NEW ENGLAND MEDICAL CORP.
2274 ALBANY POST RD.
WALDEN, NY 12586 US
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Contact STEVEN FODOR
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 07/05/2000
Decision Date 02/01/2001
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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