PHACOGARD
FDA 510(k) clearance K002932 · decided 2001-01-04
Clearance details
- K-number
- K002932
- Device name
- PHACOGARD
- Applicant
- Syntec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-20
- Decision date
- 2001-01-04
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Winfield, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.