FDA 510(k) Application Details - K984434

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K984434
Device Name Laparoscope, General & Plastic Surgery
Applicant MEDIVISION SCOPE SERVICE CENTER, INC.
1440 S. STATE COLLEGE BLVD.
#1D
ANAHEIM, CA 92806 US
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Contact WAYNE B STERNER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 12/14/1998
Decision Date 03/17/1999
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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