TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES— 510(k) K940903

Name: FDA 510(k) clearance K940903
Creator: U.S. Food and Drug Administration
Published: 1994-04-14

Substantially Equivalent

Medical Insights, Inc.

FDA 510(k) clearance K940903 for TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES, Substantially Equivalent on 1994-04-14. Applicant: Medical Insights, Inc.. Device class: 1.

Clearance details

Applicant: Medical Insights, Inc.
Product code: Code KBM
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1994-02-24
Decision date: 1994-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mystic, CT, US

Download summary PDF View on FDA.gov ↗

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