FDA 510(k) Application Details - K964833

Device Classification Name Syringe, Irrigating (Non Dental)

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510(K) Number K964833
Device Name Syringe, Irrigating (Non Dental)
Applicant RESEARCH MEDICAL, INC.
6864 SOUTH 300 WEST
MIDVALE, UT 84047 US
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Contact RD HIBBERT
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Regulation Number 880.6960

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Classification Product Code KYZ
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Date Received 12/02/1996
Decision Date 02/19/1997
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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