CERVICATH— 510(k) K881414
Substantially EquivalentEpcom Medical Systems, Inc.
FDA 510(k) clearance K881414 for CERVICATH, Substantially Equivalent on 1988-06-14. Applicant: Epcom Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Epcom Medical Systems, Inc.
- Product code
- Code HDR
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Livermore, CA, US
Recent devices under product code HDR
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