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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K831270
Device Name DISPOS. MEDICATION NEBULIZER
Applicant
HOSPITAK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HOSPITAK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/19/1983
Decision Date 06/08/1983
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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