The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Argon Microsurigal Protocols.
Device ID | K810740 |
510k Number | K810740 |
Device Name: | ARGON MICROSURIGAL PROTOCOLS |
Classification | Laser, Ent Microsurgical Carbon-dioxide |
Applicant | LUMENIS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EWG |
CFR Regulation Number | 874.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-19 |
Decision Date | 1981-08-21 |