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 |