FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUTINOVA HYDRO
K Number: K905688
·
Decision Apr 1, 1991
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
21
Applicant Total
45
Review Days
103
Basic Information
- Device Name
- CUTINOVA HYDRO
- K Number
- K905688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- BEIERSDORF, INC.
- Date Received
- December 19, 1990
- Decision Date
- April 1, 1991
- Product Code
- KOZ
- 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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IODOSORB GEL
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DERMASORB WOUND CONTACT LAYER DRESSING
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ALLEVYN DRESSING CLAIMS CHANGE
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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 |