GYNESCOPE— 510(k) K880195
Substantially EquivalentMedgyn Products, Inc.
FDA 510(k) clearance K880195 for GYNESCOPE, Substantially Equivalent on 1988-03-14. Applicant: Medgyn Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Medgyn Products, Inc.
- Product code
- Code HEX
- Device class
- Class 2
- Regulation
- 21 CFR 884.1630
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Downers Grove, IL, US
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