The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monoject Laryngotracheal Anesthesia Kit.
Device ID | K760877 |
510k Number | K760877 |
Device Name: | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT |
Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCT |
CFR Regulation Number | 868.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-04 |
Decision Date | 1976-12-09 |