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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, thermal regulating
510(k) Number K811742
FOIA Releasable 510(k) K811742
Device Name HEMOTHERM MODEL 400
Applicant
CINCINNATI SUB-ZERO
4221 Richmond Rd., N.W.
walker,  MI  49534
Correspondent
CINCINNATI SUB-ZERO
4221 Richmond Rd., N.W.
walker,  MI  49534
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/19/1981
Decision Date 08/13/1981
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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