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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K833627
Device Name CIRCULATOR MINIBOOT
Applicant
Circulator Boot Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Circulator Boot Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.5225
Classification Product Code
DRN  
Date Received10/14/1983
Decision Date 05/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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