The following data is part of a premarket notification filed by Laser Industries Of Tel Aviv with the FDA for Laser Bronchoscope.
Device ID | K822136 |
510k Number | K822136 |
Device Name: | LASER BRONCHOSCOPE |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | LASER INDUSTRIES OF TEL AVIV 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-20 |
Decision Date | 1982-08-16 |