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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEM.
Regulation Number: 888.3650
[See Other Products with this regulation number]
510(k) Number: K032507
Device Name: INTERLOK BIO-MODULAR HUMERAL STEMS
Applicant: BIOMET, INC.
56 BELL DR.
PO BOX 587
WARSAW, IN 46581 0587
Contact: PATRICIA S BERES
Product Code: KWT
[See Other Manufacturers that make this Product]
Date Received: 08-14-2003
Decision Date: 09-05-2003
Decision: SE
Advisory Committee: OR
Statement/Summary/Purged Status: Summary
Type: Special
Review by Third Party: N
Expedited Review: N
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