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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K802281
Device Name SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC
Applicant
Sherwood Medical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sherwood Medical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received09/19/1980
Decision Date 10/03/1980
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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