Atlas FDA

EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)

FDA 510(k) clearance K954021 · decided 1995-10-24

Clearance details

K-number
K954021
Device name
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
Applicant
Johnson & Johnson Professionals, Inc.
Decision
Substantially Equivalent
Date received
1995-07-31
Decision date
1995-10-24
Days to decision
85 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82- recall (Z-1533-06)Codman & Shurtleff, Inc.2006-09-29