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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: PUMP, INFUSION, PATIENT CONTROLLED ANALGESIA (PCA)
Regulation Number: 880.5725
[See Other Products with this regulation number]
510(k) Number: K032233
Device Name: MEDLEY PCA MODULE, MODEL 8120
Applicant: ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.

SAN DIEGO, CA 92121
Contact: STACEY L LEWIS
Product Code: MEA
[See Other Manufacturers that make this Product]
Date Received: 07-21-2003
Decision Date: 09-09-2003
Decision: SE
Advisory Committee: HO
Statement/Summary/Purged Status: Summary
Type: Traditional
Review by Third Party: N
Expedited Review: N
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