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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K942457
Device Name GRAFT THROMBECTOMY INSTRUMENTS
Applicant
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact R ALDEN KAY
Correspondent
INTRAMED LABORATORIES, INC.
11100 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact R ALDEN KAY
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/24/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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