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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K941869
Device Name SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
Applicant
The Lighthouse For the Blind, Inc.
2501 S. Plum St.
P.O. Box C-14119
Seattle,  WA  98114
Applicant Contact RENEE OBRYCKI
Correspondent
The Lighthouse For the Blind, Inc.
2501 S. Plum St.
P.O. Box C-14119
Seattle,  WA  98114
Correspondent Contact RENEE OBRYCKI
Regulation Number880.6320
Classification Product Code
KZF  
Date Received04/18/1994
Decision Date 08/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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