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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 K955106
Device Name BTE CPM-20
Applicant
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Applicant Contact CHRISTINE DELANEY
Correspondent
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Correspondent Contact CHRISTINE DELANEY
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/08/1995
Decision Date 12/29/1995
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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