The following data is part of a premarket notification filed by Nordan Smith Welding Supplies with the FDA for Laser Gas Mixture.
Device ID | K942865 |
510k Number | K942865 |
Device Name: | LASER GAS MIXTURE |
Classification | Powered Laser Surgical Instrument |
Applicant | NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg, MS 39403 |
Contact | William Dowden |
Correspondent | William Dowden NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg, MS 39403 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-17 |
Decision Date | 1994-08-23 |