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510(k) K833601

ANTRUM & ATTIC MIRROR by Microtek Medical, Inc. — Product Code KAI

K833601 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "ANTRUM & ATTIC MIRROR". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code KAI (Mirror, Ent), a Class I device regulated under 21 CFR 874.4420. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
October 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Microtek Medical, Inc.

  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K110358 — VENODYNE V810 (May 5, 2011)
  • K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (February 23, 2011)
  • K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA (January 25, 2007)
  • K060200 — MICROTEK MEDICAL WARMING DRAPE (May 31, 2006)
  • K050322 — MICROTEK EQUIPMENT DRAPES (May 17, 2005)
  • K022903 — CHILLBUSTER (November 27, 2002)
  • K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (May 16, 2002)
  • K011318 — VENODYNE DVT ADVANTAGE PLUS (October 25, 2001)
  • K001802 — VENODYNE DVT ADVANTAGE MODEL 610 (January 9, 2001)

Other clearances for product code KAI

  • K823915 — MIRROR TIP (January 21, 1983)
  • K822374 — BUCKINGHAM ATTIC & ANTRUM MIRROR (September 9, 1982)
  • K822261 — LARYNGEAL MIRRORS (August 30, 1982)
  • K822191 — HEAD MIRROR WITH HEADBAND (August 20, 1982)
  • K820354 — ATMOS MIRROR WARMER (March 1, 1982)
  • K781750 — MIRROR WARMER (January 17, 1979)
  • K770053 — MIRROR, LARYNGEAL (January 18, 1977)
  • K770054 — MIRROR, NASO-PHARYNX (January 18, 1977)

FDA data resources