FDA 510(k) Application Details - K982842

Device Classification Name Syringe, Piston

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510(K) Number K982842
Device Name Syringe, Piston
Applicant ELI LILLY AND CO.
LILLY CORPORATE CENTER
DROP CODE 4002
INDIANAPOLIS, IN 46285 US
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Contact LEEANN CHAMBERS
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 08/12/1998
Decision Date 09/25/1998
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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