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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K882275
Device Name STERILE PACK (PROCEDURAL TRAY/KITS)
Applicant
East Texas Lighthouse For the Blind
1716 Forest Ave.
Tyler,  TX  75702 -3901
Applicant Contact DAN O NWAELELE
Correspondent
East Texas Lighthouse For the Blind
1716 Forest Ave.
Tyler,  TX  75702 -3901
Correspondent Contact DAN O NWAELELE
Regulation Number878.4800
Classification Product Code
LRP  
Date Received05/31/1988
Decision Date 07/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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