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FDA 510(k), K190251, RecoveryRx
FDA 510(k), K190251, RecoveryRx
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510(K) Number: K190251
Device Name: RecoveryRx
Manufacturer: Sree N Koneru
Device Classification Name: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation Number: ILX
Classification Product Code: KXA
Date Received: 02/07/2019
Decision Date: 06/28/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: RecoveryRx
Manufacturer: Sree N Koneru
Device Classification Name: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation Number: ILX
Classification Product Code: KXA
Date Received: 02/07/2019
Decision Date: 06/28/2019
Decision: Substantially Equivalent (SESE)
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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