510(k) K905069
K905069 is an FDA 510(k) premarket notification submitted by Perstorp AB C/O Robert Joel Slomoff for the device "IODOSORB GEL". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Perstorp AB C/O Robert Joel Slomoff has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1991
- Date Received
- November 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Beads, Hydrophilic, For Wound Exudate Absorption
- Device Class
- Class I
- Regulation Number
- 878.4018
- Review Panel
- SU
- Submission Type