HEEL GARD— 510(k) K790954
Substantially EquivalentFem-Gard, Inc.
FDA 510(k) clearance K790954 for HEEL GARD, Substantially Equivalent on 1979-06-20. Applicant: Fem-Gard, Inc.. Device class: 1.
Clearance details
- Applicant
- Fem-Gard, Inc.
- Product code
- Code FRK
- Device class
- Class 1
- Regulation
- 21 CFR 880.6140
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FRK
view allData sourced from openFDA. This site is unofficial and independent of the FDA.