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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name valve, non-rebreathing
510(k) Number K810348
Device Name CM 3
Applicant
INSTRUMENTATION INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INSTRUMENTATION INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/10/1981
Decision Date 02/23/1981
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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