The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Heimlich Micro Trach.
Device ID | K895130 |
510k Number | K895130 |
Device Name: | HEIMLICH MICRO TRACH |
Classification | Tube, Tracheostomy (w/wo Connector) |
Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | E.martin Chamberlain |
Correspondent | E.martin Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
Product Code | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-17 |
Decision Date | 1989-11-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEIMLICH MICRO TRACH 77641368 not registered Dead/Abandoned |
TyTek Industries Inc. 2008-12-30 |
HEIMLICH MICRO TRACH 74095919 1700389 Dead/Cancelled |
INNOVATIVE MEDICAL DEVELOPMENT CORP. 1990-09-11 |