FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BIODERM MEDICAL TRANSPARENT FILM DRESSING
K Number: K951842
·
Decision Jun 12, 1995
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
14
Review Days
53
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Basic Information
- Device Name
- BIODERM MEDICAL TRANSPARENT FILM DRESSING
- K Number
- K951842
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioderm, Inc.
- Date Received
- April 20, 1995
- Decision Date
- June 12, 1995
- Product Code
- MGP
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGP), ordered by most recent decision date.
COLLATEK FOAM
FDA 510(k)
FDA Unclassified
·Unknown
COLLATEK SHEET
FDA 510(k)
FDA Unclassified
·Unknown
LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K963602 | BIODERM PVP FOAM WOUND DRESSING | Oct 30, 1996 | Substantially Equivalent |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Jun 21, 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 |