The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for C4.
| Device ID | K970143 |
| 510k Number | K970143 |
| Device Name: | C4 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad, CA 92008 |
| Contact | Alan Bunting |
| Correspondent | Alan Bunting CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad, CA 92008 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-15 |
| Decision Date | 1997-10-29 |
| Summary: | summary |