FDA 510(k) Application Details - K050209

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K050209
Device Name Laparoscope, General & Plastic Surgery
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact JANICE HASELTON
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/28/2005
Decision Date 11/23/2005
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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