510(k) K961341
K961341 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CONVERTORS POLYOLEFIN FABRIC GOWNS". The FDA issued a decision of Substantially Equivalent on Oct 28, 1996. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1996
- Date Received
- Apr 8, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
- 510(k)