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510(k) K781750

MIRROR WARMER by Arleton Technical Products, Inc. — Product Code KAI

K781750 is an FDA 510(k) premarket notification submitted by Arleton Technical Products, Inc. for the device "MIRROR WARMER". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code KAI (Mirror, Ent), a Class I device regulated under 21 CFR 874.4420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
October 16, 1978
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 for product code KAI

  • K833601 — ANTRUM & ATTIC MIRROR (January 3, 1984)
  • 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)
  • K770053 — MIRROR, LARYNGEAL (January 18, 1977)
  • K770054 — MIRROR, NASO-PHARYNX (January 18, 1977)

FDA data resources