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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 K812774
Device Name VENTILATOR CIRCUIT
Applicant
Hudson Oxygen Therapy Sales Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hudson Oxygen Therapy Sales Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5975
Classification Product Code
BZO  
Date Received10/05/1981
Decision Date 10/23/1981
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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