FLORASEAL, MODEL FS350D
FDA 510(k) clearance K083354 · decided 2009-07-20
Clearance details
- K-number
- K083354
- Device name
- FLORASEAL, MODEL FS350D
- Applicant
- Adhezion Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2008-11-13
- Decision date
- 2009-07-20
- Days to decision
- 249 days
- Clearance type
- Abbreviated
- Product code
- NZP
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hudson, NC, 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 |
|---|---|---|
| SecurePortIV Advanced Catheter Securement Adhesive (K223669) | Adhezion Biomedical, LLC | 2023-06-12 |
| SecurePortIV Catheter Securement Adhesive (K170505) | Adhezion Biomedical, LLC | 2017-09-29 |
| INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (K052870) | Kimberly-Clark Corp. | 2006-09-29 |
Recalls involving this device
No recalls on record reference this clearance.