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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K921131
Device Name CKS OSCILLATING SAW BLADE
Applicant
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Applicant Contact DAVID SAMSON
Correspondent
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Correspondent Contact DAVID SAMSON
Regulation Number878.4820
Classification Product Code
HWE  
Date Received03/10/1992
Decision Date 06/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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