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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K962849
Device Name CATHETER INSERTION TRAY
Applicant
MEDCARE MEDICAL GROUP, INC.
234 OLD HOMESTEAD HWY.
EAST SWANZEY,  NH  03446
Applicant Contact CRAIG J BELL
Correspondent
MEDCARE MEDICAL GROUP, INC.
234 OLD HOMESTEAD HWY.
EAST SWANZEY,  NH  03446
Correspondent Contact CRAIG J BELL
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/22/1996
Decision Date 10/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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