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510(k) K843234

CITOMAT AUTOCLAVES by Lic-Orthion — Product Code ECG

K843234 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "CITOMAT AUTOCLAVES". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code ECG (Sterilizer, Boiling Water), a Class I device regulated under 21 CFR 872.6710. Lic-Orthion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
August 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Boiling Water
Device Class
Class I
Regulation Number
872.6710
Review Panel
DE
Submission Type

Other clearances by Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (April 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (June 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (June 12, 1985)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K843233 — ANATOM SYSTEM (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830848 — RESI-WALKER (April 5, 1983)
  • K830855 — SESAM TREATMENT TABLE (April 5, 1983)

Other clearances for product code ECG

  • K895164 — EAGLE DS (November 17, 1989)
  • K811237 — MAGNETIC RETENTION UNIT (June 16, 1981)
  • K810977 — ENDODONTIC POST SYSTEMS (May 13, 1981)
  • K790290 — NEY EQUI-HINGE (April 10, 1979)
  • K790078 — BAR & RIDER, SCREWS, TUBES (February 27, 1979)
  • K771266 — STEAM STERILIZER (August 2, 1977)

FDA data resources