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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
Device Name LUBE JELLY SURINGE
Applicant
NURSE ASSIST, INC.
4409 Haltom Rd
Haltom City,  TX  76117
Applicant Contact BILL KANEWSKE
Correspondent
NURSE ASSIST, INC.
4409 Haltom Rd
Haltom City,  TX  76117
Correspondent Contact BILL KANEWSKE
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received05/09/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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