The following data is part of a premarket notification filed by Bobbs Medical, Inc. with the FDA for Injection Needle.
| Device ID | K834403 |
| 510k Number | K834403 |
| Device Name: | INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | BOBBS MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485002749 | K834403 | 000 |