The following data is part of a premarket notification filed by Perstorp Ab C/o Robert Joel Slomoff with the FDA for Iodosorb Powder.
Device ID | K870559 |
510k Number | K870559 |
Device Name: | IODOSORB POWDER |
Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
Applicant | PERSTORP AB C/O ROBERT JOEL SLOMOFF 9229 CRANFORD DR. Potomac, MD 20854 |
Contact | Joel Slomoff |
Correspondent | Joel 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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-03-20 |