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510(k) K890285

PROSTHETIC CEMENT REMOVER by Albert K. Chin — Product Code LZV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1989
Date Received
January 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Cement Removal Extraction
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

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  • K904180 — PROSTHETIC CEMENT REMOVER (November 20, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)