510(k) K922785
K922785 is an FDA 510(k) premarket notification submitted by Autovage for the device "IRRIVAGE". The FDA issued a decision of Substantially Equivalent on October 16, 1992. The device falls under product code EYF (Protector, Wound, Plastic), a Class I device regulated under 21 CFR 878.4014. Autovage has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1992
- Date Received
- June 9, 1992
- 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