The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Safety Needle.
| Device ID | K051019 |
| 510k Number | K051019 |
| Device Name: | SAFETY NEEDLE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Contact | Peter Rumswinkel |
| Correspondent | Peter Rumswinkel SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-22 |
| Decision Date | 2005-07-25 |