ENVISION G31 P.E. PAK
FDA 510(k) clearance K832424 · decided 1983-09-12
Clearance details
- K-number
- K832424
- Device name
- ENVISION G31 P.E. PAK
- Applicant
- Envision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-22
- Decision date
- 1983-09-12
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.