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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 K991840
Device Name FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
Applicant
BERNARD B. FRESCO
40 SAINT CLAIR AVE EAST 303
TORONTO, ONTARIO,  CA M4T 1M9
Applicant Contact BERNARD B FRESCO
Correspondent
BERNARD B. FRESCO
40 SAINT CLAIR AVE EAST 303
TORONTO, ONTARIO,  CA M4T 1M9
Correspondent Contact BERNARD B FRESCO
Regulation Number886.1930
Classification Product Code
HKY  
Date Received05/28/1999
Decision Date 03/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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