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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K935601
Device Name 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
Applicant
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Applicant Contact THOMAS P DIMAIO
Correspondent
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Correspondent Contact THOMAS P DIMAIO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/19/1993
Decision Date 01/21/1994
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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