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 |