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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gauge, Depth, Instrument, Dental
510(k) Number K890493
Device Name FLORIDA PROBE PERIODONTAL PROBE
Applicant
Florida Probe Corp.
1820 NE 23rd Ave.
Gainesville,  FL  32609
Applicant Contact GIBBS, PHD
Correspondent
Florida Probe Corp.
1820 NE 23rd Ave.
Gainesville,  FL  32609
Correspondent Contact GIBBS, PHD
Regulation Number872.4565
Classification Product Code
EIL  
Date Received01/31/1989
Decision Date 03/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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