The following data is part of a premarket notification filed by American Stair-glide Corp. with the FDA for Tubmate.
| Device ID | K811301 |
| 510k Number | K811301 |
| Device Name: | TUBMATE |
| Classification | Adaptor, Hygiene |
| Applicant | AMERICAN STAIR-GLIDE CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | ILS |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-11 |
| Decision Date | 1981-05-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TUBMATE 73329827 1224925 Live/Registered |
American Stair-Glide Corporation 1981-09-28 |