The following data is part of a premarket notification filed by Perimed, Inc. with the FDA for Pf404/409/410/411/416/418 W/pf319:0/319:1/319:2.
| Device ID | K935495 |
| 510k Number | K935495 |
| Device Name: | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PERIMED, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 -3910 |
| Contact | Oystein Lind |
| Correspondent | Oystein Lind PERIMED, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 -3910 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-15 |
| Decision Date | 1994-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000509 | K935495 | 000 |
| 07332834000479 | K935495 | 000 |
| 07332834000394 | K935495 | 000 |
| 07332834000387 | K935495 | 000 |