510(k) K875076
K875076 is an FDA 510(k) premarket notification submitted by Florida Probe Corp. for the device "FLORIDA PROBE". The FDA issued a decision of Substantially Equivalent on March 10, 1988. The device falls under product code EIX (Probe, Periodontic), a Class I device regulated under 21 CFR 872.4565. Florida Probe Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1988
- Date Received
- December 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Periodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type