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510(k) K973749

FRAG COMMANDER by Scieran Technologies, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1997
Date Received
October 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Scieran Technologies, Inc.

  • K974253 — CPD COMMANDER (February 25, 1998)
  • K980085 — PHACO COMMANDER (February 24, 1998)
  • K961738 — VIT COMMANDER SYSTEM (November 25, 1996)
  • K960767 — LIGHT COMMANDER (August 26, 1996)

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