FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
KALTOGEL WOUND DRESSING
K Number: K940407
·
Decision Apr 7, 1994
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
5
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KALTOGEL WOUND DRESSING
- K Number
- K940407
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Calgon Corp.
- Date Received
- January 27, 1994
- Decision Date
- April 7, 1994
- Product Code
- KMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMF), ordered by most recent decision date.
TearRepair Liquid Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
Rochal Bioshield Silicone Film
FDA 510(k)
FDA Class 1
·General Hospital
Aleo BME Liquid Bandage
FDA 510(k)
FDA Class 1
·General Hospital
Cavilon Advanced High Endurance Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
Atteris No-Sting Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital