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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
Regulation Number: 876.1500
[See Other Products with this regulation number]
510(k) Number: K032430
Device Name: ACUEITY MEDICAL LIGHT SOURCE
Applicant: ACUEITY, INC.
100 HAMILTON AVE., SUITE 140

PALO ALTO, CA 94301
Contact: NANCY LINCE
Product Code: FCW
[See Other Manufacturers that make this Product]
Date Received: 08-06-2003
Decision Date: 09-05-2003
Decision: SE
Advisory Committee: SU
Statement/Summary/Purged Status: Summary
Type: Traditional
Review by Third Party: Y
Expedited Review: N
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