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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 K010998
Device Name LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
Applicant
Langham Ophthalmic Technologies
9 Candlelight Ct.
Timonium,  MD  21093
Applicant Contact MAURICE E LANGHAM
Correspondent
Langham Ophthalmic Technologies
9 Candlelight Ct.
Timonium,  MD  21093
Correspondent Contact MAURICE E LANGHAM
Regulation Number886.1930
Classification Product Code
HKX  
Date Received04/03/2001
Decision Date 06/27/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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