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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K002395
Device Name MODEL 30 CLASSIC PNEUMATONOMETER
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact DIANA PRESTON
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact DIANA PRESTON
Regulation Number886.1930
Classification Product Code
HKX  
Date Received08/07/2000
Decision Date 12/11/2000
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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