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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, surgical with orthopedic accessories, ac-powered
510(k) Number K924094
Device Name MEND APC
Applicant
MEND TECHNOLOGIES, INC.
5757 ALPHA RD.
SUITE 304
DALLAS,  TX  75240
Applicant Contact PARKE
Correspondent
MEND TECHNOLOGIES, INC.
5757 ALPHA RD.
SUITE 304
DALLAS,  TX  75240
Correspondent Contact PARKE
Regulation Number878.4960
Classification Product Code
JEA  
Date Received08/13/1992
Decision Date 03/30/1993
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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