The following data is part of a premarket notification filed by Hart Enterprises, Inc. with the FDA for Pencil Point Spinal Needle.
| Device ID | K921683 |
| 510k Number | K921683 |
| Device Name: | PENCIL POINT SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Contact | Ron Demak |
| Correspondent | Ron Demak HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1993-08-26 |