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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K935582
Device Name TUBE, INHALER OXYGEN
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 Number868.5975
Classification Product Code
BZO  
Date Received11/18/1993
Decision Date 01/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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