KARICKHOFF FLYING CORPUSCLE VIEWER
FDA 510(k) clearance K831829 · decided 1983-10-19
Clearance details
- K-number
- K831829
- Device name
- KARICKHOFF FLYING CORPUSCLE VIEWER
- Applicant
- Surgidev Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-07
- Decision date
- 1983-10-19
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- HIX
- Device class
- 1
- Regulation number
- 886.1435
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERILE CAST PADDING (K801554) | Medi-Spec | 1980-08-04 |
Recalls involving this device
No recalls on record reference this clearance.