510(k) K885045
K885045 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH". The FDA issued a decision of Substantially Equivalent on Mar 3, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 1989
- Date Received
- Dec 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)