MODEL 8100 PRE-FILLED INTRAUTERINE— 510(k) K790418
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K790418 for MODEL 8100 PRE-FILLED INTRAUTERINE, Substantially Equivalent on 1979-03-21. Applicant: Ge Medical Systems Information Technologies. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code KXO
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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