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510(k) K994148

3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM by Implant Innovations, Inc. — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2000
Date Received
December 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K063403 — CONICAL ANGLED ABUTMENT (March 20, 2007)
  • K061629 — CERTAIN PREVAIL DENTAL IMPLANT (February 23, 2007)
  • K062432 — NANOTITE DENTAL IMPLANTS (February 22, 2007)
  • K061969 — PREFORMANCE POSTS AND TEMPORARY CYLINDERS (July 21, 2006)
  • K061177 — PROVIDE TEMPORARY CYLINDER (May 16, 2006)
  • K060291 — PREFORMANCE TEMPORARY CYLINDER (February 27, 2006)
  • K053170 — PREFORMANCE POSTS (February 1, 2006)

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