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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K974598
Device Name MICROKERATOME OR THE MATE
Applicant
HOWARD INSTRUMENTS, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405 -5747
Applicant Contact JACK HOWARD
Correspondent
HOWARD INSTRUMENTS, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405 -5747
Correspondent Contact JACK HOWARD
Regulation Number886.4370
Classification Product Code
HNO  
Date Received12/09/1997
Decision Date 04/22/1998
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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