The following data is part of a premarket notification filed by Safe-tec Clinical Products, Inc. with the FDA for Safepette Dispenser.
| Device ID | K890109 |
| 510k Number | K890109 |
| Device Name: | SAFEPETTE DISPENSER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland, PA 18974 |
| Contact | G Kendrick |
| Correspondent | G Kendrick SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland, PA 18974 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-02-23 |