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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K860329
Device Name FYODOROV RADIAL KERATOTOMY MARKER SET
Applicant
Med-Tech Develoment Corp.
11300 49th St. N.
Clearwater,  FL  33520
Applicant Contact JOSE H BEDOYA
Correspondent
Med-Tech Develoment Corp.
11300 49th St. N.
Clearwater,  FL  33520
Correspondent Contact JOSE H BEDOYA
Regulation Number884.4550
Classification Product Code
HHR  
Date Received01/29/1986
Decision Date 02/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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