The following data is part of a premarket notification filed by Para Scientific Co. with the FDA for Paracon Plus Formalin - Pcp-f, Paracon Plus Saf - Pcp-saf And Paracon Plus Mf - Pcp-mf.
| Device ID | K964144 |
| 510k Number | K964144 |
| Device Name: | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF |
| Classification | Device, Specimen Collection |
| Applicant | PARA SCIENTIFIC CO. 17170 WALL ST. Lake Oswego, OR 97034 |
| Contact | Eric Carlson |
| Correspondent | Eric Carlson PARA SCIENTIFIC CO. 17170 WALL ST. Lake Oswego, OR 97034 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-17 |
| Decision Date | 1996-11-27 |