The following data is part of a premarket notification filed by Regional Master Corp. with the FDA for Pinpoint Needle.
| Device ID | K853478 |
| 510k Number | K853478 |
| Device Name: | PINPOINT NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | REGIONAL MASTER CORP. P.O. BOX 431832 Miami, FL 33143 |
| Contact | Margarita Plaza |
| Correspondent | Margarita Plaza REGIONAL MASTER CORP. P.O. BOX 431832 Miami, FL 33143 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-14 |
| Decision Date | 1986-01-15 |