FDA 510(k) Application Details - K974336

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K974336
Device Name Laparoscope, General & Plastic Surgery
Applicant J-LLOYD MEDICAL, INC.
415 COMMERCE LN., SUITE 6
WEST BERLIN, NJ 08091 US
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Contact JAMES L SKAGGS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/18/1997
Decision Date 02/13/1998
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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