FDA 510(k) Application Details - K012644

Device Classification Name Laparoscope, General & Plastic Surgery, Reprocessed

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510(K) Number K012644
Device Name Laparoscope, General & Plastic Surgery, Reprocessed
Applicant SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
3636 E COLUMBINE DR.
PHOENIX, AZ 85032-5655 US
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Contact ROBERT S MCQUATE
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Regulation Number 876.1500

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Classification Product Code NLM
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Date Received 08/13/2001
Decision Date 07/29/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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