FDA 510(k) Application Details - K961222

Device Classification Name Lubricant, Patient

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510(K) Number K961222
Device Name Lubricant, Patient
Applicant PHARMACEUTICAL INNOVATIONS, INC.
1575 EYE STREET, N.W.
WASHINGTON, DC 20005 US
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Contact LARRY R PILOT
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Regulation Number 880.6375

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Classification Product Code KMJ
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Date Received 03/28/1996
Decision Date 06/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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