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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K850811
Device Name PAD, PRE-OPERATIVE PREPARATION
Applicant
East Texas Lighthouse For the Blind
1716 Forest Ave.
Tyler,  TX  75702
Applicant Contact JON E SAMSILL
Correspondent
East Texas Lighthouse For the Blind
1716 Forest Ave.
Tyler,  TX  75702
Correspondent Contact JON E SAMSILL
Regulation Number880.6060
Classification Product Code
KME  
Date Received02/28/1985
Decision Date 03/21/1985
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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