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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 K915574
Device Name COMFORT PERSONAL LUBRICANT
Applicant
Hyman, Phelps & McNamara, P.C.
C/O Dynamic Concepts
21300 Victory Ln.
Woodland Hills,  CA  91367
Applicant Contact PATRICK NOONAN
Correspondent
Hyman, Phelps & McNamara, P.C.
C/O Dynamic Concepts
21300 Victory Ln.
Woodland Hills,  CA  91367
Correspondent Contact PATRICK NOONAN
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received12/12/1991
Decision Date 02/19/1993
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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