BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT

FDA 510(k) clearance K100360 · decided 2010-07-13

Clearance details

K-number

K100360

Device name

BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT

Applicant

Cochlear Americas

Decision

Substantially Equivalent

Date received

2010-02-12

Decision date

2010-07-13

Days to decision

151 days

Clearance type

Traditional

Product code

LXB

Device class

2

Regulation number

874.3302

Medical specialty

Ear, Nose, Throat

Advisory committee

Ear, Nose, Throat

Location

Centennial, CO, US

Third-party review

No

Expedited review

No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant