The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Airways-oropharyngeal.
Device ID | K810099 |
510k Number | K810099 |
Device Name: | AIRWAYS-OROPHARYNGEAL |
Classification | Airway, Oropharyngeal, Anesthesiology |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAE |
CFR Regulation Number | 868.5110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-14 |
Decision Date | 1981-02-05 |