FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DERMAFILE (CAT. # 38
K Number: K813360
·
Decision Mar 18, 1982
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
20
Review Days
108
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Basic Information
- Device Name
- DERMAFILE (CAT. # 38
- K Number
- K813360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Exco, Inc.
- Date Received
- November 30, 1981
- Decision Date
- March 18, 1982
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Exco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844203 | ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 | Jan 2, 1985 | Substantially Equivalent |
| K844175 | ENTERNAL FEEDING TUBE-POLYURETHANE EF504 | Jan 2, 1985 | Substantially Equivalent |
| K844174 | FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI | Dec 7, 1984 | Substantially Equivalent |
| K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | Jan 30, 1984 | Substantially Equivalent |
| K831802 | LIFE VAC #2191 & 2192 | Jan 11, 1984 | Substantially Equivalent |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | Dec 29, 1983 | Substantially Equivalent |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Apr 5, 1983 | Substantially Equivalent |
| K822879 | ENTERAL NUTRITION 1 | Nov 16, 1982 | Substantially Equivalent |
| K822691 | VYGON EPIDURAL ANAESTHESIA TRAY | Oct 15, 1982 | Substantially Equivalent |
| K822836 | MICROFLEX-VENOFLUX | Oct 15, 1982 | Substantially Equivalent |