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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 K972555
Device Name CATHETER TUNNELER
Applicant
GERARD MEDICAL, INC.
6 CITY DEPOT RD.
P.O. BOX 940
CHARLTON CITY,  MA  01508
Applicant Contact RICHARD CAYER
Correspondent
GERARD MEDICAL, INC.
6 CITY DEPOT RD.
P.O. BOX 940
CHARLTON CITY,  MA  01508
Correspondent Contact RICHARD CAYER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/07/1997
Decision Date 12/22/1997
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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