FDA 510(k) Application Details - K011538

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K011538
Device Name Laparoscope, General & Plastic Surgery
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact ELIZABETH MILLER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 05/18/2001
Decision Date 08/09/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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