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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name component, traction, invasive
510(k) Number K884798
Device Name AME PINSITE SHIELD(TM)
Applicant
AMERICAN MEDICAL ELECTRONICS, INC.
4125 keller springs rd., ste
144
dallas,  TX  75244
Applicant Contact clayton thacker
Correspondent
AMERICAN MEDICAL ELECTRONICS, INC.
4125 keller springs rd., ste
144
dallas,  TX  75244
Correspondent Contact clayton thacker
Regulation Number888.3040
Classification Product Code
JEC  
Date Received11/16/1988
Decision Date 02/10/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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