The following data is part of a premarket notification filed by Spectra-physics, Inc. with the FDA for Model 770 Argon Laser.
Device ID | K781453 |
510k Number | K781453 |
Device Name: | MODEL 770 ARGON LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | SPECTRA-PHYSICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-22 |
Decision Date | 1978-10-24 |