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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Periodontic, Endodontic, Irrigating
510(k) Number K811889
Device Name R & S SERIES FITTING TOOLS
Applicant
Suncoast Dental Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Suncoast Dental Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EIC  
Date Received07/01/1981
Decision Date 07/24/1981
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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