IRRIGATION SET
FDA 510(k) clearance K822560 · decided 1982-12-03
Clearance details
- K-number
- K822560
- Device name
- IRRIGATION SET
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-24
- Decision date
- 1982-12-03
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- NBH
- Device class
- 1
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| SHOVEL RETRACTOR (K822109) | Bio-Blitz, Inc. | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.