The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Slick Set W/sureloc External Connector.
| Device ID | K810151 |
| 510k Number | K810151 |
| Device Name: | SLICK SET W/SURELOC EXTERNAL CONNECTOR |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | POLAMEDCO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-21 |
| Decision Date | 1981-02-12 |