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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K980522
Device Name REFRACTEC MCS-100
Applicant
Refractec, Inc.
27075 Cabot Rd., #115
Laguna Hills,  CA  92653
Applicant Contact MITCH CAMPBELL
Correspondent
Refractec, Inc.
27075 Cabot Rd., #115
Laguna Hills,  CA  92653
Correspondent Contact MITCH CAMPBELL
Regulation Number886.4100
Classification Product Code
HQR  
Date Received02/10/1998
Decision Date 07/22/1998
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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