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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K840841
Device Name RENEAU UNIT
Applicant
RENEAU, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RENEAU, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5470
Classification Product Code
CBF  
Date Received02/24/1984
Decision Date 08/07/1984
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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