STERILE CAST PADDING
FDA 510(k) clearance K801554 · decided 1980-08-04
Clearance details
- K-number
- K801554
- Device name
- STERILE CAST PADDING
- Applicant
- Medi-Spec
- Decision
- Substantially Equivalent
- Date received
- 1980-07-08
- Decision date
- 1980-08-04
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- HIX
- Device class
- 1
- Regulation number
- 886.1435
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| KARICKHOFF FLYING CORPUSCLE VIEWER (K831829) | Surgidev Corp. | 1983-10-19 |
Recalls involving this device
No recalls on record reference this clearance.