LAMP DELIVERY SYS.-PHOTOCOAGULATION
FDA 510(k) clearance K772213 · decided 1977-12-13
Clearance details
- K-number
- K772213
- Device name
- LAMP DELIVERY SYS.-PHOTOCOAGULATION
- Applicant
- Varian Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-02
- Decision date
- 1977-12-13
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HQB
- Device class
- 2
- Regulation number
- 886.4690
- 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.