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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 K896207
Device Name OSBON PERSONAL LUBRICANT
Applicant
Osbon Medical Systems, Ltd.
Post Office Box 1478
Augusta,  GA  30903
Applicant Contact BETTYE E GRINER
Correspondent
Osbon Medical Systems, Ltd.
Post Office Box 1478
Augusta,  GA  30903
Correspondent Contact BETTYE E GRINER
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received10/26/1989
Decision Date 12/01/1989
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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