FDA 510(k) Application Details - K980082

Device Classification Name Injector, Fluid, Non-Electrically Powered

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510(K) Number K980082
Device Name Injector, Fluid, Non-Electrically Powered
Applicant NATIONAL MEDICAL PRODUCTS, INC.
57 PARKER ST.
IRVINE, CA 92718 US
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Contact ROHIT PATEL
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Regulation Number 880.5430

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Classification Product Code KZE
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Date Received 01/09/1998
Decision Date 03/04/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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