The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Customized Tracheostomy Tubes.
Device ID | K923878 |
510k Number | K923878 |
Device Name: | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES |
Classification | Tube Tracheostomy And Tube Cuff |
Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
Contact | Harry M Kaufman |
Correspondent | Harry M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
Product Code | JOH |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-03 |
Decision Date | 1992-12-29 |