FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODERM MEDICAL HYDROGEL ISLAND DRESSING
K Number: K951166
·
Decision Jun 21, 1995
Classifications
1
FEI Numbers
292
Registration Numbers
292
Same Product Code
28
Applicant Total
14
Review Days
99
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Basic Information
- Device Name
- BIODERM MEDICAL HYDROGEL ISLAND DRESSING
- K Number
- K951166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4022
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioderm, Inc.
- Date Received
- March 14, 1995
- Decision Date
- June 21, 1995
- Product Code
- NAE
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAE), ordered by most recent decision date.
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AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
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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 |
| 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 |