510(k) K083354
- Device
- FLORASEAL, MODEL FS350D
- Applicant
- ADHEZION BIOMEDICAL
- 510(k) number
- K083354
- Product code
- NZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-20
- Date received
- 2008-11-13
- Regulation
- 878.4370
- Classification name
- Sealant, Microbial
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD JONES
- Address
- 506 Pine Mountain Rd. Hudson NC US 28638 28638
FDA Registration Numbers#
- 3015173212
- 3015443199
- 2246552
- 3006385287
- 1450662
- 1047843
- 9617175
- 3008132398
- 3012494290
Source Documents#
Other 510(k) Records For Product Code NZP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223669 | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2023-06-12 |
| K170505 | SecurePortIV Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2017-09-29 |
| K052870 | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | Kimberly-Clark Corp. | 2006-09-29 |
Legacy Summary#
summary
FDA Review#
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