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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nose, Internal
510(k) Number K781574
Device Name PLASTI-PORE SEPTAL BUTTON
Applicant
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3680
Classification Product Code
FZE  
Date Received09/18/1978
Decision Date 09/27/1978
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
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