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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K870921
Device Name DENTAL NEEDLE (CARTRIDGE TYPE)
Applicant
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Applicant Contact VIVIENNE MARTIN
Correspondent
Churchill Corp.
One Summit Sq.
Rte. 413 & Doublewoods Rd.
Langhorne,  PA  19047
Correspondent Contact VIVIENNE MARTIN
Regulation Number872.4730
Classification Product Code
DZM  
Date Received03/05/1987
Decision Date 04/03/1987
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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