Atlas FDA

MEDCOMP SC4

FDA 510(k) clearance K022678 · decided 2003-02-24

Clearance details

K-number
K022678
Device name
MEDCOMP SC4
Applicant
Medcomp
Decision
Unknown
Date received
2002-08-12
Decision date
2003-02-24
Days to decision
196 days
Clearance type
Traditional
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Harleysville, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.