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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 K853653
Device Name SANA-LUBE
Applicant
Huntington Laboratories, Inc.
970 E. Tipton
Huntington,  IN  46750
Applicant Contact ROBERT MACDONALD
Correspondent
Huntington Laboratories, Inc.
970 E. Tipton
Huntington,  IN  46750
Correspondent Contact ROBERT MACDONALD
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received09/03/1985
Decision Date 11/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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