The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Neotech Mucus Trap W/catheter.
Device ID | K890425 |
510k Number | K890425 |
Device Name: | NEOTECH MUCUS TRAP W/CATHETER |
Classification | Catheters, Suction, Tracheobronchial |
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 | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-26 |
Decision Date | 1989-04-19 |