The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular.
Device ID | K073516 |
510k Number | K073516 |
Device Name: | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
Contact | Pamela Segale |
Correspondent | Pamela Segale KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-14 |
Decision Date | 2008-02-21 |
Summary: | summary |