BAERVELT PARS PLANA GLAUCOMA IMPLANT
FDA 510(k) clearance K955455 · decided 1997-02-18
Clearance details
- K-number
- K955455
- Device name
- BAERVELT PARS PLANA GLAUCOMA IMPLANT
- Applicant
- Pharmacia Iovision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1997-02-18
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Peapack, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.