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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Dental Hand
510(k) Number K772316
Device Name MATRIX STRIP, DEAD-SOFT
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
DZN  
Date Received12/19/1977
Decision Date 01/03/1978
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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