FDA 510(k) Application Details - K020252

Device Classification Name Syringe, Piston

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510(K) Number K020252
Device Name Syringe, Piston
Applicant HARVEST TECHNOLOGIES, CORP.
40 GRISSOM RD, SUITE 100
PLYMOUTH, MA 02360 US
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Contact JOHN D BONASERA
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 01/24/2002
Decision Date 04/05/2002
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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