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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K831142
Device Name INSPIRATORY RESISTOR KIT
Applicant
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5690
Classification Product Code
BWF  
Date Received04/07/1983
Decision Date 06/03/1983
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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