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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K811409
Device Name ARGYLE CPAP NASAL CANNULA
Applicant
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/19/1981
Decision Date 06/02/1981
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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