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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K810559
Device Name OPTI- SYSTEM
Applicant
CORPAK CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CORPAK CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/03/1981
Decision Date 03/17/1981
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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