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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K950293
Device Name TEC-2110 GREEN LASER MODEL MT-HNG
Applicant
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Applicant Contact DONALD RIIBE
Correspondent
Medtec, Inc.
1401 8th St. SE
P.O. Box 602
Orange City,  IA  51041
Correspondent Contact DONALD RIIBE
Regulation Number892.5780
Classification Product Code
IWE  
Date Received01/25/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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