FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
K Number: K844052
·
Decision Jan 23, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
97
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Basic Information
- Device Name
- BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
- K Number
- K844052
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Woodroof Laboratories, Inc.
- Date Received
- October 18, 1984
- Decision Date
- January 23, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Woodroof Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790496 | BIOBRANE BRAND TEMPORARY WOUND DRESSING | May 3, 1979 | Substantially Equivalent |