URIAS PRESSURE SPLINTS, & FIRST AID
FDA 510(k) clearance K831764 · decided 1983-09-12
Clearance details
- K-number
- K831764
- Device name
- URIAS PRESSURE SPLINTS, & FIRST AID
- Applicant
- Svenol Andersen
- Decision
- Substantially Equivalent
- Date received
- 1983-06-01
- Decision date
- 1983-09-12
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FZF
- Device class
- 1
- Regulation number
- 878.3900
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Svenol Andersen
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COMPRESAID (K881516) | R. Evans Corp. | 1988-04-29 |
| INFLATABLE FULL LEG SPLINT (K874051) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FOOT & ANKLE SPLINT (K874050) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE HALF LEG SPLINT (K874052) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FULL ARM SPLINT (K874053) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE AIR SPLINTS (K853600) | Hospitak, Inc. | 1985-09-19 |
Recalls involving this device
No recalls on record reference this clearance.