510(k) K912790
K912790 is an FDA 510(k) premarket notification submitted by Unicor Federal Dept. of Justice for the device "SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on September 19, 1991. The device falls under product code FYE (Dress, Surgical), a Class I device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1991
- Date Received
- June 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dress, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- SU
- Submission Type