The following data is part of a premarket notification filed by Eclipse, Inc. with the FDA for Model 550-dc Crossfire(tm).
| Device ID | K945564 |
| 510k Number | K945564 |
| Device Name: | MODEL 550-DC CROSSFIRE(TM) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ECLIPSE, INC. P.O. BOX 50875 Palo Alto, CA 94303 |
| Contact | Anne-marie De Merlier |
| Correspondent | Anne-marie De Merlier ECLIPSE, INC. P.O. BOX 50875 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-06-01 |