Atlas FDA

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

FDA 510(k) clearance K153041 · decided 2016-03-14

Clearance details

K-number
K153041
Device name
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Applicant
Integra LifeSciences Corporation
Decision
Substantially Equivalent
Date received
2015-10-19
Decision date
2016-03-14
Days to decision
147 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Planisboro, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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