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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 K101522
Device Name ULTRA SEAL STERILE LUBRICATING JELLY
Applicant
Ultra Seal Corporation
521 Main St.
New Paltz,  NY  12561
Applicant Contact JAMES DAVIS
Correspondent
Ultra Seal Corporation
521 Main St.
New Paltz,  NY  12561
Correspondent Contact JAMES DAVIS
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received06/02/2010
Decision Date 12/23/2010
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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