510(k) K070048— GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

Substantially Equivalent

Marian Medical, Inc.

Clearance details

Applicant
Marian Medical, Inc.
Product code
Code FCM
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Louisville, KY, US
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