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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nail
510(k) Number K850803
Device Name NAIL SPLINT
Applicant
Inro Medical Designs, Inc.
2727 Bolton Boone Dr., #105
P.O. Box 9
Desoto,  TX  75115
Applicant Contact OLAYINKA OGUNRO
Correspondent
Inro Medical Designs, Inc.
2727 Bolton Boone Dr., #105
P.O. Box 9
Desoto,  TX  75115
Correspondent Contact OLAYINKA OGUNRO
Classification Product Code
MQZ  
Date Received02/27/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
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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