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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, Pneumatic Powered & Accessory/Attachment
510(k) Number K844131
Device Name NUCLEOTOME
Applicant
Medical Instrument Development Laboratories, Inc.
2235 Polvorosa Ave.
Suite 200
San Leandro,  CA  94577
Applicant Contact WILLIAM T GEORGE
Correspondent
Medical Instrument Development Laboratories, Inc.
2235 Polvorosa Ave.
Suite 200
San Leandro,  CA  94577
Correspondent Contact WILLIAM T GEORGE
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received10/23/1984
Decision Date 11/29/1984
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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