FDA 510(k) Application Details - K001220

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K001220
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact TAMIMA ITANI
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 04/17/2000
Decision Date 05/16/2000
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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