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510(k) K020304

DISPOSABLE LIGHT HANDLE AND ADAPTOR by Aspen Surgical Products, Inc. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2002
Date Received
January 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Aspen Surgical Products, Inc.

  • K030339 — CAUTERY TIP CLEANER, MODEL-TC-100 (March 7, 2003)

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  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)