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 |