The following data is part of a premarket notification filed by Pro-tec Containers, Inc. with the FDA for Pro-ject(tm) Safety Needle Holder.
| Device ID | K892665 |
| 510k Number | K892665 |
| Device Name: | PRO-JECT(TM) SAFETY NEEDLE HOLDER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | PRO-TEC CONTAINERS, INC. 3 MORGAN #D Irvine, CA 92718 |
| Contact | Ralph T Hagins |
| Correspondent | Ralph T Hagins PRO-TEC CONTAINERS, INC. 3 MORGAN #D Irvine, CA 92718 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-10-04 |