The following data is part of a premarket notification filed by Medical Repackers Co. with the FDA for Iqk-200.
| Device ID | K881313 |
| 510k Number | K881313 |
| Device Name: | IQK-200 |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
| Contact | Billy A Hodges |
| Correspondent | Billy A Hodges MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-05-19 |