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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 K910790
Device Name MENTOR LUBRICATING JELLY
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact LYNN R BRECKENRIDGE
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact LYNN R BRECKENRIDGE
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received02/25/1991
Decision Date 05/03/1991
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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