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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K781294
Device Name PROSTHESIS, KNEE, TOTAL
Applicant
BIOMET, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOMET, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/27/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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