510(k) K913030
K913030 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MAX-I-PROBE IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 1991. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1991
- Date Received
- July 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Oral Irrigation
- Device Class
- Class I
- Regulation Number
- 872.6510
- Review Panel
- DE
- Submission Type