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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K960889
Device Name SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS
Applicant
San Diego Swiss Machining, Inc.
8910 University Center Ln.,
Suite 265
San Diego,  CA  92122
Applicant Contact ALAN DONALD
Correspondent
San Diego Swiss Machining, Inc.
8910 University Center Ln.,
Suite 265
San Diego,  CA  92122
Correspondent Contact ALAN DONALD
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/04/1996
Decision Date 05/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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