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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K923428
Device Name PANDA
Applicant
ETAC US, INC.
2325 PARKLAWN DRIVE, SUITE P
WAUKESHA,  WI  53186
Applicant Contact MELODY B DILL
Correspondent
ETAC US, INC.
2325 PARKLAWN DRIVE, SUITE P
WAUKESHA,  WI  53186
Correspondent Contact MELODY B DILL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/13/1992
Decision Date 03/04/1993
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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