The following data is part of a premarket notification filed by Pharma-plast Usa, Inc. with the FDA for Pharma-plast Needle.
| Device ID | K852442 |
| 510k Number | K852442 |
| Device Name: | PHARMA-PLAST NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-09-20 |