PHX TECHNOLOGIES CORP.,HOOK ELECTRODE, 5MM
FDA 510(k) clearance K934281 · decided 1994-02-25
Clearance details
- K-number
- K934281
- Device name
- PHX TECHNOLOGIES CORP.,HOOK ELECTRODE, 5MM
- Applicant
- Phx Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-31
- Decision date
- 1994-02-25
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lewisville, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.