EARLENS— 510(k) K854311

Substantially Equivalent

Sound Acoustic Systems, Ltd.

FDA 510(k) clearance K854311 for EARLENS, Substantially Equivalent on 1986-04-14. Applicant: Sound Acoustic Systems, Ltd..

Clearance details

Applicant: Sound Acoustic Systems, Ltd.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1985-10-25
Decision date: 1986-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna, CA, US

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