SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
FDA 510(k) clearance K912739 · decided 1991-08-28
Clearance details
- K-number
- K912739
- Device name
- SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
- Applicant
- Site Microsurgical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-21
- Decision date
- 1991-08-28
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.