510(k) K896176
K896176 is an FDA 510(k) premarket notification submitted by Controlled Therapeutics Corp. for the device "EXUSORB(TM) DRY/WET DRESSING". The FDA issued a decision of Substantially Equivalent on November 24, 1989. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Controlled Therapeutics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1989
- Date Received
- October 25, 1989
- 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