IMPERVIOUS ISOLATION SHOE COVERS
FDA 510(k) clearance K923187 · decided 1993-01-29
Clearance details
- K-number
- K923187
- Device name
- IMPERVIOUS ISOLATION SHOE COVERS
- Applicant
- Dynatech Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1992-06-30
- Decision date
- 1993-01-29
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- FXW
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rockwall, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.