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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, manual
510(k) Number K992998
Device Name AUTOMATED OPHTHALMICS SOFTIPS
Applicant
AUTOMATED OPHTHALMICS, INC.
8253 GLEMAR RD.
ELLICOTT,  MD  21043
Applicant Contact NORMAN BICKMAN
Correspondent
AUTOMATED OPHTHALMICS, INC.
8253 GLEMAR RD.
ELLICOTT,  MD  21043
Correspondent Contact NORMAN BICKMAN
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/07/1999
Decision Date 01/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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