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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nose, Internal
510(k) Number K782104
Device Name PASTE, PRO CARE PROPHYLAXIS
Applicant
Young Dental Manufacturing Co. 1, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Young Dental Manufacturing Co. 1, LLC
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.3680
Classification Product Code
FZE  
Date Received12/19/1978
Decision Date 01/03/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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