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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 K113689
Device Name DUKAL LUBRICATING JELLY
Applicant
Dukal Corporation
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Applicant Contact PATRICK J LAMB
Correspondent
Dukal Corporation
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Correspondent Contact PATRICK J LAMB
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received12/15/2011
Decision Date 05/04/2012
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
Predetermined Change
Control Plan Authorized		 No
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