The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Intubation Procedure Kit.
Device ID | K772046 |
510k Number | K772046 |
Device Name: | INTUBATION PROCEDURE KIT |
Classification | Stylet, Tracheal Tube |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSR |
CFR Regulation Number | 868.5790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-28 |
Decision Date | 1977-11-23 |