FDA 510(k) Premarket Notification K023703: BI-OSTETIC

Submission Details & Decision

Normalized public record details for 510(k) notification K023703.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K023703

Applicant / Sponsor

Berkeley Advanced Biomaterials, Inc.

Device Name

BI-OSTETIC

Product Code

MQV

Decision Date

2003-01-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-11-04

Related Establishments / Registrations

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