LARGE WOUND DRESSING KIT
FDA 510(k) clearance K803119 · decided 1980-12-30
Clearance details
- K-number
- K803119
- Device name
- LARGE WOUND DRESSING KIT
- Applicant
- American Medical Disposable, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-10
- Decision date
- 1980-12-30
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KDD
- Device class
- 1
- Regulation number
- 878.4800
- 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 American Medical Disposable
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.