510(k) K896828
K896828 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "BIOCLUSIVE(R) ABSORBENT DRESSING". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. Johnson & Johnson International has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1990
- Date Received
- December 4, 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