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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K972326
Device Name PEBA ANCHOR/SUTURE COMBINATION
Applicant
ORTHOPAEDIC BIOSYSTEMS, LTD.
7320 EAST BUTHERUS
SUITE 206
SCOTSDALE,  AZ  85260
Applicant Contact JEFFREY B SKIBA
Correspondent
ORTHOPAEDIC BIOSYSTEMS, LTD.
7320 EAST BUTHERUS
SUITE 206
SCOTSDALE,  AZ  85260
Correspondent Contact JEFFREY B SKIBA
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received06/23/1997
Decision Date 02/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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