FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODERM PVP FOAM WOUND DRESSING
K Number: K963602
·
Decision Oct 30, 1996
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
221
Applicant Total
14
Review Days
51
Basic Information
- Device Name
- BIODERM PVP FOAM WOUND DRESSING
- K Number
- K963602
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIODERM, INC.
- Date Received
- September 9, 1996
- Decision Date
- October 30, 1996
- 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
Other Clearances by BIODERM, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING | May 18, 1999 | Substantially Equivalent |
| K982778 | BIODERM FOAM WOUND DRESSING | Oct 21, 1998 | Substantially Equivalent |
| K982939 | BTF THIN FILM WOUND DRESSING | Oct 13, 1998 | Substantially Equivalent |
| K980451 | BIODERM CALCIUM ALGINATE DRESSING | Apr 9, 1998 | Substantially Equivalent for Some Indications |
| K973429 | BIODERM FOAM WOUND DRESSING | Dec 1, 1997 | Substantially Equivalent for Some Indications |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | Jan 10, 1997 | Substantially Equivalent |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Jun 21, 1995 | Substantially Equivalent |
| K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING | Jun 12, 1995 | Substantially Equivalent |
| K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING | Jun 9, 1995 | Substantially Equivalent |
| K950619 | BIODERM MEDICAL FOAM WOUND DRESSING | Apr 25, 1995 | Substantially Equivalent |