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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: ALLOY, GOLD BASED, FOR CLINICAL USE
Regulation Number: 872.3060
[See Other Products with this regulation number]
510(k) Number: K032493
Device Name: ALEXANDER
Applicant: IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.

AMHERST, NY 14228
Contact: ANDERJEET S GULATI
Product Code: EJT
[See Other Manufacturers that make this Product]
Date Received: 08-16-2003
Decision Date: 09-04-2003
Decision: SE
Advisory Committee: DE
Statement/Summary/Purged Status: Statement
Type: Traditional
Review by Third Party: N
Expedited Review: N
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