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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cement Removal Extraction
510(k) Number K891472
Device Name IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
Applicant
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Applicant Contact PETER J SCRANTON
Correspondent
Implant Technology, Inc.
400 Plz. Dr.
Secaucus,  NJ  07094
Correspondent Contact PETER J SCRANTON
Regulation Number888.4580
Classification Product Code
LZV  
Date Received03/15/1989
Decision Date 05/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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