The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Hypodermic Pinpoint™ Gt Needle.
| Device ID | K163437 |
| 510k Number | K163437 |
| Device Name: | Hypodermic Pinpoint™ GT Needle |
| Classification | Non-stainless Steel Needle |
| Applicant | C. R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Jamie Howell |
| Correspondent | Jamie Howell C. R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | PVZ |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-06-23 |
| Summary: | summary |