FDA 510(k) Application Details - K051720

Device Classification Name Syringe, Piston

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510(K) Number K051720
Device Name Syringe, Piston
Applicant SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact KATHY ANDERSON
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 06/27/2005
Decision Date 07/25/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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