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FDA 510(k) Applications for Medical Device Product Code "PCT"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K223249
DxTx Medical, Inc.
Pro-Tx Endorectal Balloon (PROT-25)
02/10/2023
K141958
EDGE MEDICAL LLC
ERB ENDORECTAL BALLOON
11/18/2014
K150234
Myriad Medical, LLC
Myriad Prostate Caddy┐ Immobilization Rectal Balloon Item #9901,3301
03/31/2015
K180478
QLRAD International Ltd.
RectalPro 75 Endorectal Balloon
11/13/2018
DEN130036
RADIADYNE
PROSTATE IMMOBILIZER RECTAL BALLOON
01/28/2014
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