Atlas FDA

PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY

FDA 510(k) clearance K072509 · decided 2007-11-26

Clearance details

K-number
K072509
Device name
PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY
Applicant
Medcomp
Decision
Substantially Equivalent
Date received
2007-09-06
Decision date
2007-11-26
Days to decision
81 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
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.