FREEDOM MARK III SURGICAL HELMET SYSTEM
FDA 510(k) clearance K910515 · decided 1991-05-06
Clearance details
- K-number
- K910515
- Device name
- FREEDOM MARK III SURGICAL HELMET SYSTEM
- Applicant
- Stackhouse Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-05
- Decision date
- 1991-05-06
- Days to decision
- 90 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
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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