The following data is part of a premarket notification filed by Perstorp Ab C/o Robert Joel Slomoff with the FDA for Iodosorb Gel.
| Device ID | K905069 |
| 510k Number | K905069 |
| Device Name: | IODOSORB GEL |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | PERSTORP AB C/O ROBERT JOEL SLOMOFF 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | Slomoff |
| Correspondent | Slomoff PERSTORP AB C/O ROBERT JOEL SLOMOFF 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-09 |
| Decision Date | 1991-01-31 |