FDA 510(k) Application Details - K000048

Device Classification Name Syringe, Piston

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510(K) Number K000048
Device Name Syringe, Piston
Applicant BIOSURGICAL CORP.
5990 STONERIDGE AVE.,
SUITE 112
PLEASANTON, CA 94566 US
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Contact TERRY LAAS
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 01/07/2000
Decision Date 01/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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