FDA 510(k) Application Details - K962147

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K962147
Device Name Laparoscope, General & Plastic Surgery
Applicant MEDICAL CREATIVE TECHNOLOGIES, INC.
2950-N ADVANCE LN.
COLMAR, PA 18915-9727 US
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Contact PERK CROOK
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/03/1996
Decision Date 07/09/1996
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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