FDA 510(k) Application Details - K052048

Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal

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510(K) Number K052048
Device Name Dislodger, Stone, Basket, Ureteral, Metal
Applicant PERCUTANEOUS SYSTEMS, INCORPORATED
1300 CRITTENDEN LANE
SUITE 301
MOUNTAIN VIEW, CA 94043 US
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Contact THOMAS LAWSON
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Regulation Number 876.4680

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Classification Product Code FFL
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Date Received 07/29/2005
Decision Date 09/13/2005
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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