510(k) K905688
- Device
- CUTINOVA HYDRO
- Applicant
- BEIERSDORF, INC.
- 510(k) number
- K905688
- Product code
- KOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-01
- Date received
- 1990-12-19
- Regulation
- 878.4018
- Classification name
- Beads, Hydrophilic, For Wound Exudate Absorption
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VINCENT MILANO
- Address
- 360 Martin Luther King Dr. P.O. Box 5529 Norwalk CT US 06856 06856
FDA Registration Numbers#
- 3010034780
- 1649518
- 3017417635
- 3037031822
- 3012309743
- 3012421607
- 3012852163
- 8043484
- 3021282544
- 3003965134
- 3003744503
- 3017299525
- 3008386507
- 3010275504
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K905206 | INCARE PINSITE DRESSING | Hollister, Inc. | 1991-04-12 |
| K905069 | IODOSORB GEL | Perstorp AB C/O Robert Joel Slomoff | 1991-01-31 |
| K904604 | REDI-RELEASE ABSORBENT DRESSING | Fountain Pharmaceuticals, Inc. | 1991-01-07 |
| K903645 | DERMASORB WOUND CONTACT LAYER DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1990-11-21 |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | Johnson & Johnson International | 1990-11-21 |
| K904412 | ALLEVYN DRESSING CLAIMS CHANGE | Smith & Nephew United, Inc. | 1990-10-23 |
| K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) | Smith & Nephew United, Inc. | 1990-06-28 |
| K896176 | EXUSORB(TM) DRY/WET DRESSING | Controlled Therapeutics Corp. | 1989-11-24 |
| K895354 | INTRASITE CAVITY WOUND DRESSING | Smith & Nephew United, Inc. | 1989-11-07 |
| K874552 | ENVISAN PAD | Marion Laboratories, Inc. | 1988-01-22 |
| K872453 | DEBRISAN ABSORBENT PAD | Pharmacia, Inc. | 1988-01-14 |
| K874553 | ENVISAN PASTE | Marion Laboratories, Inc. | 1987-12-18 |
| K872117 | DEXTRANOMER | Interworld, Inc. | 1987-07-24 |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | American Pharmaseal Div. Ahsc | 1987-03-27 |
| K870559 | IODOSORB POWDER | Perstorp AB C/O Robert Joel Slomoff | 1987-03-20 |
Legacy Summary#
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FDA Review#
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