510(k) K864307
K864307 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)". The FDA issued a decision of Substantially Equivalent on November 18, 1986. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1986
- Date Received
- November 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Periodontic, Endodontic, Irrigating
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type