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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K950390
Device Name URETHRAL CATHETERIZATION TRAY
Applicant
MEDCARE CUSTOM PACKAGING, INC.
234 OLD HOMESTEAD HIGHWAY
ROUTE 32
EAST SWANZEY,  NH  03446
Applicant Contact WILLIAM A HAYS
Correspondent
MEDCARE CUSTOM PACKAGING, INC.
234 OLD HOMESTEAD HIGHWAY
ROUTE 32
EAST SWANZEY,  NH  03446
Correspondent Contact WILLIAM A HAYS
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
KNY  
Date Received02/01/1995
Decision Date 05/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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