Atlas FDA

ECHOSTIM FACET TIP

FDA 510(k) clearance K063380 · decided 2007-04-25

Clearance details

K-number
K063380
Device name
ECHOSTIM FACET TIP
Applicant
Havel'S, Inc.
Decision
Substantially Equivalent
Date received
2006-11-08
Decision date
2007-04-25
Days to decision
168 days
Clearance type
Traditional
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Cincinnati, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.