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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K873698
Device Name STERILIZED DENTAL BIT PACKAGING
Applicant
Florida Diamond Instruments Corp.
1429 Colonial Blvd.
Fort Myers,  FL  33907
Applicant Contact SCHNEIDER
Correspondent
Florida Diamond Instruments Corp.
1429 Colonial Blvd.
Fort Myers,  FL  33907
Correspondent Contact SCHNEIDER
Regulation Number872.3240
Classification Product Code
EJL  
Date Received09/14/1987
Decision Date 12/03/1987
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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