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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 K935342
Device Name SCMD KERATOME
Applicant
S.C.M.D. KERATOMES OF ARIZONA
16833 E. PARLIN DR.
FTN. HILLS,  AZ  85268
Applicant Contact C RICHARD SMITH
Correspondent
S.C.M.D. KERATOMES OF ARIZONA
16833 E. PARLIN DR.
FTN. HILLS,  AZ  85268
Correspondent Contact C RICHARD SMITH
Regulation Number886.4370
Classification Product Code
HNO  
Date Received11/05/1993
Decision Date 04/01/1994
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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