510(k) K904389
K904389 is an FDA 510(k) premarket notification submitted by David F. Trungale for the device "SI-PRO". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code EYF (Protector, Wound, Plastic), a Class I device regulated under 21 CFR 878.4014.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1990
- Date Received
- September 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Wound, Plastic
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- SU
- Submission Type