STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
FDA 510(k) clearance K043004 · decided 2005-03-16
Clearance details
- K-number
- K043004
- Device name
- STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
- Applicant
- Viasys Medsystems
- Decision
- Substantially Equivalent
- Date received
- 2004-11-01
- Decision date
- 2005-03-16
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wheeling, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.