The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Spinal Needle, Models: 405081, 405235, 405236, 405237.
Device ID | K081446 |
510k Number | K081446 |
Device Name: | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | Pasquale Amato |
Correspondent | Pasquale Amato BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-22 |
Decision Date | 2008-07-17 |
Summary: | summary |