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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K940647
Device Name ORBSCAN(TM) KERATOMETER
Applicant
Orbtek, Inc.
3030 S. Main St.
Suite 600
Salt Lake City,  UT  84115
Applicant Contact ROBERT P BYARD
Correspondent
Orbtek, Inc.
3030 S. Main St.
Suite 600
Salt Lake City,  UT  84115
Correspondent Contact ROBERT P BYARD
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received02/15/1994
Decision Date 07/06/1994
Decision Substantially Equivalent (SESE)
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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