The following data is part of a premarket notification filed by Pioneer Intl. Co. with the FDA for Disposable Needle, Aspiration And Injection.
| Device ID | K893233 |
| 510k Number | K893233 |
| Device Name: | DISPOSABLE NEEDLE, ASPIRATION AND INJECTION |
| Classification | Syringe, Piston |
| Applicant | PIONEER INTL. CO. 5550 PENLAND RD., Hidden Hills, CA 91302 |
| Contact | David Hsiung |
| Correspondent | David Hsiung PIONEER INTL. CO. 5550 PENLAND RD., Hidden Hills, CA 91302 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-28 |
| Decision Date | 1990-01-04 |