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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, All Types
510(k) Number K760657
Device Name RACESTYPTINE CORD
Applicant
Septodont, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Septodont, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EIG  
Date Received09/15/1976
Decision Date 09/27/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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