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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 K862730
Device Name DANNIFLEX 400SL
Applicant
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Applicant Contact INC.
Correspondent
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Correspondent Contact INC.
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/18/1986
Decision Date 07/24/1986
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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