510(k) K261522— BioWave BioWraps

Substantially Equivalent

Biowave Corporation

Clearance details

Applicant: Biowave Corporation
Product code: Code GXY
Advisory panel: Neurology
Date received: 2026-05-07
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Westport, CT, US

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