FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEUKOFIX POROS
K Number: K792726
·
Decision Feb 28, 1980
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
45
Review Days
59
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Basic Information
- Device Name
- LEUKOFIX POROS
- K Number
- K792726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Beiersdorf, Inc.
- Date Received
- December 31, 1979
- Decision Date
- February 28, 1980
- Product Code
- FPX
- 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPX), ordered by most recent decision date.
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BIOSTRIP STERILE WOUND CLOSURE STRIP
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DUKAL SKIN CLOSURE STRIP
FDA 510(k)
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SPYROFLEX WOUND CLOSURES
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Beiersdorf, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Dec 18, 2009 | Substantially Equivalent |
| K024057 | CURAD SCAR THERAPY | Jun 18, 2003 | Substantially Equivalent |
| K952526 | CUTINOVA CAVITY | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K943363 | CUTIPLAST STERIL | Mar 15, 1995 | Substantially Equivalent |
| K944581 | CUTINOVA THIN WOUND DRESSING | Dec 2, 1994 | Substantially Equivalent for Some Indications |
| K935630 | NORTA | Oct 7, 1994 | Substantially Equivalent |
| K940378 | COVERLET ADHESIVE DRESSING | Jul 29, 1994 | Substantially Equivalent for Some Indications |
| K925630 | ELASTOPLAST HEAT PLASTER | Feb 25, 1994 | Substantially Equivalent |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |