The following data is part of a premarket notification filed by Minitube Of America, Inc with the FDA for Minitube Temperature Control Unit Sc-2000 + 2045.
Device ID | K050197 |
510k Number | K050197 |
Device Name: | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 |
Classification | Accessory, Assisted Reproduction |
Applicant | MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison, WI 53703 |
Contact | Frederick T Rikkers |
Correspondent | Frederick T Rikkers MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison, WI 53703 |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-27 |
Decision Date | 2006-10-06 |