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510(k) K813490

VERSION OF A CLOSED-FLOW SYS. CALORIC by Thomas M. Foti, M.D. — Product Code ETF

K813490 is an FDA 510(k) premarket notification submitted by Thomas M. Foti, M.D. for the device "VERSION OF A CLOSED-FLOW SYS. CALORIC". The FDA issued a decision of Substantially Equivalent on January 7, 1982. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1982
Date Received
December 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type

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  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)

FDA data resources