GM501 Mineral Oil— 510(k) K191552
Substantially EquivalentHamilton Thorne, Inc.
FDA 510(k) clearance K191552 for GM501 Mineral Oil, Substantially Equivalent on 2019-09-18. Applicant: Hamilton Thorne, Inc.. Device class: 2.
Clearance details
- Applicant
- Hamilton Thorne, Inc.
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Beverly, MA, US
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