The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Clinicon Universal Waveguide Handpiece And Fiber Tips.
| Device ID | K014048 |
| 510k Number | K014048 |
| Device Name: | CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego, CA 92128 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego, CA 92128 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850013050123 | K014048 | 000 |
| 00850013050017 | K014048 | 000 |
| 00850013050024 | K014048 | 000 |
| 00850013050031 | K014048 | 000 |
| 00850013050048 | K014048 | 000 |
| 00850013050055 | K014048 | 000 |
| 00850013050062 | K014048 | 000 |
| 00850013050079 | K014048 | 000 |
| 00850013050086 | K014048 | 000 |
| 00850013050093 | K014048 | 000 |
| 00850013050116 | K014048 | 000 |
| 00850013050000 | K014048 | 000 |