MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045— 510(k) K050197
Substantially EquivalentMinitube of America, Inc.
FDA 510(k) clearance K050197 for MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045, Substantially Equivalent on 2006-10-06. Applicant: Minitube of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Minitube of America, Inc.
- Product code
- Code MQG
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
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