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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Instrument, Ac-Powered, Ophthalmic
510(k) Number K853358
Device Name RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM
Applicant
DENTSPLY INTL.
96 CALDWELL DR.
CINCINNATI,  OH  45216
Applicant Contact SEMMELMAN
Correspondent
DENTSPLY INTL.
96 CALDWELL DR.
CINCINNATI,  OH  45216
Correspondent Contact SEMMELMAN
Regulation Number886.1860
Classification Product Code
HMF  
Date Received08/12/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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