The following data is part of a premarket notification filed by Becton Dickson & Co. with the FDA for Bd Spinal Needle 27g.
Device ID | K091758 |
510k Number | K091758 |
Device Name: | BD SPINAL NEEDLE 27G |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | BECTON DICKSON & CO. 1 BECTON DR. MC237 Franklin Lakes, NJ 07417 -1880 |
Contact | Pasquale Amato |
Correspondent | Pasquale Amato BECTON DICKSON & CO. 1 BECTON DR. MC237 Franklin Lakes, NJ 07417 -1880 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-16 |
Decision Date | 2009-10-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382904051445 | K091758 | 000 |
50382904050813 | K091758 | 000 |