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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K852097
Device Name PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
Applicant
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact ALBERT P SEPRINSKI
Correspondent
MEDI-TECH, INC.
480 PLESANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact ALBERT P SEPRINSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received05/15/1985
Decision Date 11/01/1985
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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