KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
FDA 510(k) clearance K011115 · decided 2001-05-02
Clearance details
- K-number
- K011115
- Device name
- KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
- Applicant
- Heinz Kurz GmbH Medizintechnik
- Decision
- Substantially Equivalent
- Date received
- 2001-04-12
- Decision date
- 2001-05-02
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- MML
- Device class
- 2
- Regulation number
- 886.5700
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Amsterdam, Nh, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.