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FDA 510(k), K122950, LASER HELMET
FDA 510(k), K122950, LASER HELMET
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$49.00 USD
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510(K) Number: K122950
Device Name: LASER HELMET
Manufacturer: THERADOME INC.
Device Classification Name: laser, comb, hair
Regulation Number: 890.5500
Classification Product Code: OAP
Date Received: 09/25/2012
Decision Date: 06/14/2013
Regulation Medical Specialty: Physical Medicine
Device Name: LASER HELMET
Manufacturer: THERADOME INC.
Device Classification Name: laser, comb, hair
Regulation Number: 890.5500
Classification Product Code: OAP
Date Received: 09/25/2012
Decision Date: 06/14/2013
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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