Atlas FDA

ulrich Transfer Set

FDA 510(k) clearance K161723 · decided 2016-12-21

Clearance details

K-number
K161723
Device name
ulrich Transfer Set
Applicant
Ulrich GmbH & Co. KG
Decision
Substantially Equivalent
Date received
2016-06-22
Decision date
2016-12-21
Days to decision
182 days
Clearance type
Traditional
Product code
PQH
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Ulm, DE
Third-party review
No
Expedited review
No

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MEDRAD® Imaging Bulk Package Transfer Set (K173913)Bayer U.S., LLC2018-05-04
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Recalls involving this device

No recalls on record reference this clearance.