Atlas FDA

MEDIGROUP KEY TUBE

FDA 510(k) clearance K013017 · decided 2001-12-06

Clearance details

K-number
K013017
Device name
MEDIGROUP KEY TUBE
Applicant
Janin Group, Inc.
Decision
Substantially Equivalent
Date received
2001-09-07
Decision date
2001-12-06
Days to decision
90 days
Clearance type
Traditional
Product code
FJS
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Naperville, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.