ENDOCYTE— 510(k) K843941
Substantially EquivalentGyneco, Inc.
FDA 510(k) clearance K843941 for ENDOCYTE, Substantially Equivalent on 1985-02-25. Applicant: Gyneco, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyneco, Inc.
- Product code
- Code HFE
- Device class
- Class 2
- Regulation
- 21 CFR 884.1100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flemington, NJ, US
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