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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Instrument, Powered, Ophthalmic
510(k) Number K922242
Device Name 910T MONTORIZED INSTRUMENT TABLE
Applicant
R.H. Burton Co.
3965 Brookham Dr.
P.O. Box 68
Grove City,  OH  43123
Applicant Contact TAMMY KERN
Correspondent
R.H. Burton Co.
3965 Brookham Dr.
P.O. Box 68
Grove City,  OH  43123
Correspondent Contact TAMMY KERN
Regulation Number886.4855
Classification Product Code
HRJ  
Date Received05/13/1992
Decision Date 09/30/1992
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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