The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Vent-o2-cath.
Device ID | K760371 |
510k Number | K760371 |
Device Name: | VENT-O2-CATH |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | DRYDEN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-08-13 |