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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 K820128
FOIA Releasable 510(k) K820128
Device Name UNI-SET
Applicant
INHALATION THERAPY EQUIPMENT, CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INHALATION THERAPY EQUIPMENT, CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5975
Classification Product Code
BZO  
Date Received01/18/1982
Decision Date 03/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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