FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BTF THIN FILM WOUND DRESSING
K Number: K982939
·
Decision Oct 13, 1998
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
- BTF THIN FILM WOUND DRESSING
- K Number
- K982939
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioderm, Inc.
- Date Received
- August 21, 1998
- Decision Date
- October 13, 1998
- 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
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FDA 510(k)
FDA Unclassified
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LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
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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 |
| 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 |
| 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 |