MODEL SKCK STERILE KNOB COVER KIT
FDA 510(k) clearance K870662 · decided 1987-10-28
Clearance details
- K-number
- K870662
- Device name
- MODEL SKCK STERILE KNOB COVER KIT
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-19
- Decision date
- 1987-10-28
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- BXM
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Life-Tech Intl.
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 |
|---|---|---|
| MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K013215) | Nuvasive, Inc. | 2001-10-16 |
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| VER MED A10011 PNS DUAL ELEMENT ELECTRODE (K921498) | Vermont Medical, Inc. | 1993-06-09 |
Recalls involving this device
No recalls on record reference this clearance.