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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K935697
Device Name CIRCUMCISION TRAY
Applicant
Cush Medical Products
P.O. Box 247
881 Mountain View Dr.
Piney Flats,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
Cush Medical Products
P.O. Box 247
881 Mountain View Dr.
Piney Flats,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number884.4530
Classification Product Code
HFX  
Date Received11/30/1993
Decision Date 05/02/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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