The following data is part of a premarket notification filed by Actuated Medical, Inc with the FDA for Tubeclear.
Device ID | K121571 |
510k Number | K121571 |
Device Name: | TUBECLEAR |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ACTUATED MEDICAL, INC 310 ROLLING RIDGE DR Bellefonte, PA 16823 |
Contact | Debora Demers |
Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-05-29 |
Decision Date | 2012-06-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TUBECLEAR 86383919 4731056 Live/Registered |
Actuated Medical, Inc. 2014-09-03 |
TUBECLEAR 85662925 4373836 Live/Registered |
Actuated Medical, Inc. 2012-06-27 |