FDA 510(k) Application Details - K955282

Device Classification Name Syringe, Piston

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510(K) Number K955282
Device Name Syringe, Piston
Applicant THERMOGENESIS CORP.
11431 SUNRISE GOLD CIRCLE
SUITE A
RANCHO CORDOVA, CA 95742 US
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Contact PHILIP COELHO
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 11/16/1995
Decision Date 05/06/1996
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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