The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Giraffe2.
Device ID | K102133 |
510k Number | K102133 |
Device Name: | GIRAFFE2 |
Classification | Cord, Retraction |
Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Contact | Wendy Garman |
Correspondent | Wendy Garman KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Product Code | MVL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-29 |
Decision Date | 2010-10-07 |
Summary: | summary |