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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K163313
Device Name ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Applicant
CIVCO MEDICAL INSTRUMENTS CO., INC.
(D/B/A CIVCO MEDICAL SOLUTIONS)
6 WINTER AVE
Deep River,  CT  06417
Applicant Contact Kevin Mader
Correspondent
CIVCO MEDICAL INSTRUMENTS CO., INC.
(D/B/A CIVCO MEDICAL SOLUTIONS)
6 WINTER AVE
Deep River,  CT  06417
Correspondent Contact Kevin Mader
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/23/2016
Decision Date 06/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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