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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 K771973
Device Name GINGITRACT
Applicant
Den-Mat Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Den-Mat Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EIG  
Date Received10/17/1977
Decision Date 11/07/1977
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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