PHACO NEEDLES 1000-R & 1000-O NEEDLES
FDA 510(k) clearance K923630 · decided 1994-04-06
Clearance details
- K-number
- K923630
- Device name
- PHACO NEEDLES 1000-R & 1000-O NEEDLES
- Applicant
- O.R. Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-21
- Decision date
- 1994-04-06
- Days to decision
- 624 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tuscaloosa, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.