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 |