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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K942987
Device Name NUCLEOTOME L KIT
Applicant
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Applicant Contact CHARMAINE HENDERSON
Correspondent
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Correspondent Contact CHARMAINE HENDERSON
Regulation Number878.4820
Classification Product Code
GET  
Date Received06/20/1994
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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