510(k) K031408
K031408 is an FDA 510(k) premarket notification submitted by Deroyal for the device "DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Deroyal has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2003
- Date Received
- May 5, 2003
- 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