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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 K993122
Device Name MSP M/K BLADE
Applicant
MEDICAL STERILE PRODUCTS, INC.
RD. 413, KM. 0.2
RINCON,  PR  00677
Applicant Contact GARY C DIONNE
Correspondent
MEDICAL STERILE PRODUCTS, INC.
RD. 413, KM. 0.2
RINCON,  PR  00677
Correspondent Contact GARY C DIONNE
Regulation Number886.4370
Classification Product Code
HNO  
Date Received09/20/1999
Decision Date 03/16/2000
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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