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510(k) K781698

EXAMINER 10 by American Sterilizer Co. — Product Code HJE

K781698 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "EXAMINER 10". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code HJE (Lamp, Fluorescein, Ac-Powered), a Class II device regulated under 21 CFR 878.4580. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
October 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Fluorescein, Ac-Powered
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by American Sterilizer Co.

  • K943288 — AMSCO SQ240 SURGICAL LIGHT (October 17, 1994)
  • K931872 — THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (February 7, 1994)
  • K922485 — CHEMDI-VHP CHEMICAL INDICATOR (September 29, 1993)
  • K930493 — QUANTUM 3080 SURGICAL TABLE (June 22, 1993)
  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)

Other clearances for product code HJE

  • K922348 — VALTRAC(R) INTRODUCER FORCEP (June 9, 1992)
  • K802291 — FLUORESCENT SUN LAMP FIXTURE (October 31, 1980)

FDA data resources