SELF-CONTAINED SURGICAL SLUSH FREEZER
FDA 510(k) clearance K913777 · decided 1991-09-25
Clearance details
- K-number
- K913777
- Device name
- SELF-CONTAINED SURGICAL SLUSH FREEZER
- Applicant
- Taylor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-14
- Decision date
- 1991-09-25
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JRM
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rockton, 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 |
|---|---|---|
| ORS-100 (K921568) | Mnlase, Inc. | 1992-06-09 |
| ORS-200 (K921569) | Mnlase, Inc. | 1992-06-09 |
| ORS-300 (K921570) | Mnlase, Inc. | 1992-06-09 |
| ORS-1000 (K915427) | Mnlase, Inc. | 1992-01-07 |
| SANISERV SURGICAL SLUSH SYSTEM (K894006) | Saniserv, Inc. | 1989-11-03 |
| LANCER ICE CUBE (K782077) | Sherwood Medical Industries | 1979-04-03 |
Recalls involving this device
No recalls on record reference this clearance.