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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K862977
Device Name MEDITRADE ARTIFICIAL EYES AND IMPLANTS
Applicant
Meditrade, Inc.
Allen E. Smith And Associates
1111 Mcallen State Bank Tower
Mcallen,  TX  78501
Applicant Contact NOLAN K STUTZMAN
Correspondent
Meditrade, Inc.
Allen E. Smith And Associates
1111 Mcallen State Bank Tower
Mcallen,  TX  78501
Correspondent Contact NOLAN K STUTZMAN
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received08/07/1986
Decision Date 10/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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