The following data is part of a premarket notification filed by Pharma-plast Usa, Inc. with the FDA for Asik 'once' Syringe.
| Device ID | K852444 |
| 510k Number | K852444 |
| Device Name: | ASIK 'ONCE' SYRINGE |
| Classification | Syringe, Piston |
| Applicant | PHARMA-PLAST USA, INC. 1801 MCGILL COLLEGE AVE. SUITE 1470, MONTREAL Canada H3a 2n4, CA |
| Contact | Douglas M Bennett |
| Correspondent | Douglas M Bennett PHARMA-PLAST USA, INC. 1801 MCGILL COLLEGE AVE. SUITE 1470, MONTREAL Canada H3a 2n4, CA |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05706225001307 | K852444 | 000 |
| 05706225001123 | K852444 | 000 |
| 05706225000942 | K852444 | 000 |
| 05706225000614 | K852444 | 000 |
| 05706225001918 | K852444 | 000 |
| 05706225001871 | K852444 | 000 |