The following data is part of a premarket notification filed by Mallinckroot, Inc. with the FDA for Attachable Lanz (tentative).
| Device ID | K885216 |
| 510k Number | K885216 |
| Device Name: | ATTACHABLE LANZ (TENTATIVE) |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | MALLINCKROOT, INC. HOOK RD. Argyle, NY 12809 |
| Contact | Philip E Wiegert |
| Correspondent | Philip E Wiegert MALLINCKROOT, INC. HOOK RD. Argyle, NY 12809 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-19 |
| Decision Date | 1989-03-14 |