FDA 510(k) Application Details - K970056

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K970056
Device Name Laparoscope, General & Plastic Surgery
Applicant WOODBINE OPTICAL CORP.
41 BROOKS DR.
BRAINTREE, MA 02184 US
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Contact PAUL DIAS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/07/1997
Decision Date 01/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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