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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 K801484
Device Name ROOT CANAL FILLING APPLICATOR NEEDLES
Applicant
National Patent Development Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
National Patent Development Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EIC  
Date Received05/16/1980
Decision Date 07/21/1980
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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