510(k) K925715
K925715 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "RS OPTIGUARD GOWN & DRAPE MATERIAL". The FDA issued a decision of Substantially Equivalent on May 11, 1993. 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
- May 11, 1993
- Date Received
- Nov 12, 1992
- 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)