510(k) K901922
K901922 is an FDA 510(k) premarket notification submitted by Safte S.P.A. for the device "SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code EXN (Support, Hernia), a Class I device regulated under 21 CFR 876.5970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1990
- Date Received
- April 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Hernia
- Device Class
- Class I
- Regulation Number
- 876.5970
- Review Panel
- GU
- Submission Type