The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for Aerosol Delivery Hood.
Device ID | K882396 |
510k Number | K882396 |
Device Name: | AEROSOL DELIVERY HOOD |
Classification | Tent, Oxygen |
Applicant | VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
Contact | Joseph Creighton |
Correspondent | Joseph Creighton VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
Product Code | BYL |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-10 |
Decision Date | 1988-08-01 |