The following data is part of a premarket notification filed by Acute Ideas Co. Ltd. with the FDA for Rumble Tuff.
Device ID | K113315 |
510k Number | K113315 |
Device Name: | RUMBLE TUFF |
Classification | Pump, Breast, Powered |
Applicant | ACUTE IDEAS CO. LTD. 865 N 1430 W Orem, UT 84057 |
Contact | Matthew Kho |
Correspondent | Matthew Kho ACUTE IDEAS CO. LTD. 865 N 1430 W Orem, UT 84057 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-09 |
Decision Date | 2012-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50718122644396 | K113315 | 000 |
00822383542942 | K113315 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RUMBLE TUFF 86128307 4596010 Live/Registered |
A Cute Baby, Inc 2013-11-25 |
RUMBLE TUFF 75106380 2087311 Live/Registered |
A CUTE BABY, INC. 1996-05-20 |
RUMBLE TUFF 75106380 2087311 Live/Registered |
Peay, Connie B. 1996-05-20 |