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FDA 510(k), K030281, CRYOTRON 2 CRYOTHERAPY DEVICE
FDA 510(k), K030281, CRYOTRON 2 CRYOTHERAPY DEVICE
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510(K) Number: K030281
Device Name: CRYOTRON 2 CRYOTHERAPY DEVICE
Manufacturer: SANDRA WILLIAMSON
Device Classification Name: Vapocoolant Device
Regulation Number: MLY
Classification Product Code: KXA
Date Received: 01/27/2003
Decision Date: 08/20/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: CRYOTRON 2 CRYOTHERAPY DEVICE
Manufacturer: SANDRA WILLIAMSON
Device Classification Name: Vapocoolant Device
Regulation Number: MLY
Classification Product Code: KXA
Date Received: 01/27/2003
Decision Date: 08/20/2003
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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