PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH— 510(k) K915357
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K915357 for PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH, Substantially Equivalent on 1992-05-28. Applicant: Medtronic Vascular. Device class: 1.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code NAE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4022
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn Center, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.