Data / Medical devices / Sweden / Perstorp Specialty Chemicals AB, Perstorp Pharma
Perstorp Specialty Chemicals AB, Perstorp Pharma: FDA-registered device maker in PERSTORP Skane lan [SE-12], Sweden, 2 510(k) clearances
Perstorp Specialty Chemicals AB, Perstorp Pharma is registered with the FDA (registration 3005139112) in PERSTORP Skane lan [SE-12], Sweden. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 28, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005139112
- Address
- Perstorp Industrial Park, PERSTORP Skane lan [SE-12], Sweden, 284 80
- Owner or operator
- PERSTORP SPECIALTY CHEMICAL AB (9010119)
- Roles
- Manufacturer
- First device listed
- March 6, 2006
- Registered through
- 2026
- Brand names listed
- IODOFLEX, IODOSORB GEL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Manufacturer | accessdata.fda.gov |
| Beads, Hydrophilic, For Wound Exudate Absorption | KOZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 28, 1994 | K940414 | IODOFLEX PASTE | KMF | Substantially Equivalent for Some Indications | Oclassen Pharmaceuticals, Inc. | accessdata.fda.gov |
| January 31, 1991 | K905069 | IODOSORB GEL | KOZ | Substantially Equivalent | Perstorp AB C/O Robert Joel Slomoff | accessdata.fda.gov |
Compare with other makers
Updated April 28, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.