The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Neotech Universal Adapter.
Device ID | K882203 |
510k Number | K882203 |
Device Name: | NEOTECH UNIVERSAL ADAPTER |
Classification | Connector, Airway (extension) |
Applicant | NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
Contact | Thomas R Thornbury |
Correspondent | Thomas R Thornbury NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-25 |
Decision Date | 1988-06-17 |