The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Pinpoint Gt Needles.
Device ID | K163216 |
510k Number | K163216 |
Device Name: | Pinpoint GT Needles |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Silvia De La Barra |
Correspondent | Silvia De La Barra C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-16 |
Decision Date | 2017-06-27 |
Summary: | summary |