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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K883922
Device Name TECHMEDICA I.B.O. BLADE
Applicant
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Applicant Contact RICK A BUSS
Correspondent
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Correspondent Contact RICK A BUSS
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received09/16/1988
Decision Date 12/08/1988
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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