QUALITONE ITE GENESIS— 510(k) K904731

Substantially Equivalent

Qualitone

FDA 510(k) clearance K904731 for QUALITONE ITE GENESIS, Substantially Equivalent on 1990-12-17. Applicant: Qualitone.

Clearance details

Applicant: Qualitone
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1990-10-17
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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