The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Sureguide Co2 Laser Beam Delivery System.
Device ID | K992472 |
510k Number | K992472 |
Device Name: | SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | CLINICON CORP. 5825 AVENIDA ENCINAS, #101 Carlsbad, CA 92008 |
Contact | Gerald S Palecki |
Correspondent | Gerald S Palecki CLINICON CORP. 5825 AVENIDA ENCINAS, #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 | 1999-07-26 |
Decision Date | 1999-09-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850013050185 | K992472 | 000 |
00850013050178 | K992472 | 000 |
00850013050161 | K992472 | 000 |
00850013050154 | K992472 | 000 |