The following data is part of a premarket notification filed by Professional Instruments Co. with the FDA for Teflon-coated Hypodermic Needles/regional Block.
| Device ID | K864830 |
| 510k Number | K864830 |
| Device Name: | TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | PROFESSIONAL INSTRUMENTS CO. 10920 KINGHURST P.O. BOX 36221 Houston, TX 77099 |
| Contact | Alfred C Coats |
| Correspondent | Alfred C Coats PROFESSIONAL INSTRUMENTS CO. 10920 KINGHURST P.O. BOX 36221 Houston, TX 77099 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-01-12 |