510(k) K875076

FLORIDA PROBE by Florida Probe Corp. — Product Code EIX

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