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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, fixation, bone
510(k) Number K981798
Device Name LACTOSORB POP RIVET
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact JULIE K RYAN
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact JULIE K RYAN
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HRX   MAI  
Date Received05/21/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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