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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lubricant, patient
510(k) Number K121390
Model 1104
Device Name LUBE JELLY SURINGE
Original Applicant
NURSE ASSIST, INC.
4409 haltom rd
haltom city,  TX  76117
Original Contact bill kanewske
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received05/09/2012
Decision Date 08/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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