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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K952465
Device Name PROBE PERSONAL LUBRICANT - SILKY LIGHT
Applicant
DAVRYAN LABORATORIES, INC.
2623 S.W. PARK PL.
PORTLAND,  OR  97201
Applicant Contact BRUCE CAMPBELL
Correspondent
DAVRYAN LABORATORIES, INC.
2623 S.W. PARK PL.
PORTLAND,  OR  97201
Correspondent Contact BRUCE CAMPBELL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/26/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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