Atlas FDA

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

FDA 510(k) clearance K082106 · decided 2008-10-02

Clearance details

K-number
K082106
Device name
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
Applicant
Elcam Medical Acal
Decision
Substantially Equivalent
Date received
2008-07-25
Decision date
2008-10-02
Days to decision
69 days
Clearance type
Special
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mp. Merom Hagalil, IL
Third-party review
No
Expedited review
No

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LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
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Recalls involving this device

No recalls on record reference this clearance.