EDGE PROTECTOR, BARRIER
FDA 510(k) clearance K790306 · decided 1979-02-22
Clearance details
- K-number
- K790306
- Device name
- EDGE PROTECTOR, BARRIER
- Applicant
- Surgikos, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-13
- Decision date
- 1979-02-22
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- KGW
- Device class
- 2
- Regulation number
- 878.4370
- 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 Surgikos
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.
Recalls involving this device
No recalls on record reference this clearance.