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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K925270
Device Name EX N' FLEX EF-200
Applicant
Tecogics Scientific , Ltd.
Unit 4 72 Pretoria Ave.
Ottawa, Ontario K1s 1w9,  CA
Applicant Contact ERROL GRAY
Correspondent
Tecogics Scientific , Ltd.
Unit 4 72 Pretoria Ave.
Ottawa, Ontario K1s 1w9,  CA
Correspondent Contact ERROL GRAY
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/19/1992
Decision Date 07/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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