FDA 510(k) Application Details - K103741

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K103741
Device Name Laparoscope, General & Plastic Surgery
Applicant INTERLACE MEDICAL, INC.
135 NEWBURY STREET
FRAMINGHAM, MA 01701 US
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Contact JOHN J VOZELLA
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 12/23/2010
Decision Date 03/02/2011
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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