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510(k) K811237

MAGNETIC RETENTION UNIT by Universiti Malaya — Product Code ECG

K811237 is an FDA 510(k) premarket notification submitted by Universiti Malaya for the device "MAGNETIC RETENTION UNIT". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code ECG (Sterilizer, Boiling Water), a Class I device regulated under 21 CFR 872.6710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
May 4, 1981
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 for product code ECG

  • K895164 — EAGLE DS (November 17, 1989)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • 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