LIQUIDERM LIQUID ADHESIVE BANDAGE
FDA 510(k) clearance K002338 · decided 2001-01-29
Clearance details
- K-number
- K002338
- Device name
- LIQUIDERM LIQUID ADHESIVE BANDAGE
- Applicant
- Closure Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-01
- Decision date
- 2001-01-29
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S012) | Closure Medical Corp. | 2006-09-14 |
| HIGH VISCOSITY DERMABOND MINI APPLICATOR (P960052/S011) | Closure Medical Corp. | 2006-02-10 |
| HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE (P960052/S010) | Closure Medical Corp. | 2005-03-21 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S009) | Closure Medical Corp. | 2004-09-24 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007) | Closure Medical Corp. | 2003-12-01 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006) | Closure Medical Corp. | 2003-06-13 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004) | Closure Medical Corp. | 2002-12-31 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005) | Closure Medical Corp. | 2002-07-24 |