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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: SYRINGE, CARTRIDGE
Regulation Number: 872.6770
[See Other Products with this regulation number]
510(k) Number: K023722
Device Name: SAFETYWAND DISPOSABLE HANDPIECE
Applicant: SPINTECH, INC.
2000 M ST. NW SUITE 700

WASHINGTON, DC 20036
Contact: DANIEL J MANELLI
Product Code: EJI
[See Other Manufacturers that make this Product]
Date Received: 11-05-2002
Decision Date: 09-02-2003
Decision: SE
Advisory Committee: DE
Statement/Summary/Purged Status: Summary
Type: Traditional
Review by Third Party: N
Expedited Review: N
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