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510(k) K770861

SURGICAL COLDLIGHT, AX8 by Affiliated Hospital Products, Inc. — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1977
Date Received
May 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Affiliated Hospital Products, Inc.

  • K771942 — TILT 10, CATALOG #S-2600 (October 27, 1977)

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  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)