Atlas FDA

CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C

FDA 510(k) clearance K102875 · decided 2010-12-20

Clearance details

K-number
K102875
Device name
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
Applicant
Integra LifeSciences Corporation
Decision
Substantially Equivalent
Date received
2010-10-01
Decision date
2010-12-20
Days to decision
80 days
Clearance type
Traditional
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Planisboro, NJ, US
Third-party review
No
Expedited review
No

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