HANAULUX(R) 2000
FDA 510(k) clearance K895715 · decided 1989-10-13
Clearance details
- K-number
- K895715
- Device name
- HANAULUX(R) 2000
- Applicant
- W.C. Heraeus GmbH
- Decision
- Substantially Equivalent
- Date received
- 1989-09-25
- Decision date
- 1989-10-13
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Germany, DE
- Third-party review
- No
- Expedited review
- No
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