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510(k) K915068

PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER by American Medical Mfg., Inc. — Product Code FTA

K915068 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER". The FDA issued a decision of Substantially Equivalent on February 6, 1992. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1992
Date Received
November 8, 1991
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 American Medical Mfg., Inc.

  • K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL (April 6, 1999)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K915065 — I.V.IRRIGATION POLE (February 11, 1992)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • 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)

FDA data resources