Atlas FDA

MICROJET CRONO PCA

FDA 510(k) clearance K013822 · decided 2002-05-08

Clearance details

K-number
K013822
Device name
MICROJET CRONO PCA
Applicant
Cane S.R.L.
Decision
Substantially Equivalent
Date received
2001-11-16
Decision date
2002-05-08
Days to decision
173 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Deer Field, IL, US
Third-party review
No
Expedited review
No

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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
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Recalls involving this device

No recalls on record reference this clearance.