510(k) K884397
K884397 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL STERILE WOUND CARE DRESSING". The FDA issued a decision of Substantially Equivalent for Some Indications on Dec 27, 1988. 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
- SN (Substantially Equivalent for Some Indications)
- Decision Date
- Dec 27, 1988
- Date Received
- Oct 19, 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)