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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 K092488
Device Name DYNAREX STERILE LUBRICATING JELLY
Applicant
DYNAREX CORPORATION
10 GLENSHAW ST.
ORANGEBURG,  NY  10962
Applicant Contact DANIEL CONSAGA
Correspondent
DYNAREX CORPORATION
10 GLENSHAW ST.
ORANGEBURG,  NY  10962
Correspondent Contact DANIEL CONSAGA
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received08/13/2009
Decision Date 12/18/2009
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
Recalls CDRH Recalls
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