BIOPATCH ANTIMICROBIAL DRESSING
FDA 510(k) clearance K003229 · decided 2001-10-26
Clearance details
- K-number
- K003229
- Device name
- BIOPATCH ANTIMICROBIAL DRESSING
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-10
- Decision date
- 2001-10-26
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- SEL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K171908) | 3M Company | 2017-07-11 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) | 3M Company | 2017-05-15 |
Recalls involving this device
No recalls on record reference this clearance.