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FDA 510(k), K021837, BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
FDA 510(k), K021837, BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
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510(K) Number: K021837
Device Name: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
Manufacturer: ENTIFIC MEDICAL SYSTEMS, INC.
Device Classification Name: hearing aid, bone conduction
Regulation Number: 874.3302
Classification Product Code: LXB
Date Received: 06/04/2002
Decision Date: 08/30/2002
Regulation Medical Specialty: Ear Nose & Throat
Device Name: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
Manufacturer: ENTIFIC MEDICAL SYSTEMS, INC.
Device Classification Name: hearing aid, bone conduction
Regulation Number: 874.3302
Classification Product Code: LXB
Date Received: 06/04/2002
Decision Date: 08/30/2002
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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