FDA 510(k) Application Details - K160740

Device Classification Name Laparoscope, General & Plastic Surgery, Reprocessed

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510(K) Number K160740
Device Name Laparoscope, General & Plastic Surgery, Reprocessed
Applicant SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
2747 SW 6TH ST.
REDMOND, OR 97756 US
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Contact BRANDI J. PANTELEON
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Regulation Number 876.1500

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Classification Product Code NLM
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Date Received 03/17/2016
Decision Date 05/06/2016
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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