COMFEEL SEASORB DRESSING
FDA 510(k) clearance K983519 · decided 1998-12-30
Clearance details
- K-number
- K983519
- Device name
- COMFEEL SEASORB DRESSING
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-08
- Decision date
- 1998-12-30
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA, #11701 recall (Z-0710-2007) | Coloplast Corp Skin Care Div | 2007-04-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |