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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Surgical, Dental
510(k) Number K850906
Device Name TACTILE PLUS DENTAL ELEVATORS
Applicant
Ipco Corp.
1025 Westchester Ave.
White Plains,  NY  10604
Applicant Contact LEONARD L WOLFSON
Correspondent
Ipco Corp.
1025 Westchester Ave.
White Plains,  NY  10604
Correspondent Contact LEONARD L WOLFSON
Regulation Number872.4565
Classification Product Code
EMJ  
Date Received03/05/1985
Decision Date 04/12/1985
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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