The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Incisor I Pulsed Nd:yag Laser System.
Device ID | K922901 |
510k Number | K922901 |
Device Name: | INCISOR I PULSED ND:YAG LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-16 |
Decision Date | 1992-11-20 |