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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K940293
Device Name 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
Applicant
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Applicant Contact THOMAS P DI MAIO
Correspondent
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Correspondent Contact THOMAS P DI MAIO
Regulation Number880.5440
Classification Product Code
FPB  
Date Received01/21/1994
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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