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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 K860330
Device Name MAKLAKOV STYLE TONOMETER
Applicant
MED-TECH DEVELOMENT CORP.
11300 49TH ST. NORTH
CLEARWATER,  FL  33520
Applicant Contact JOSE H BEDOYA
Correspondent
MED-TECH DEVELOMENT CORP.
11300 49TH ST. NORTH
CLEARWATER,  FL  33520
Correspondent Contact JOSE H BEDOYA
Regulation Number886.1930
Classification Product Code
HKY  
Date Received01/29/1986
Decision Date 02/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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