Atlas FDA

SILVERSEAL

FDA 510(k) clearance K040019 · decided 2004-07-23

Clearance details

K-number
K040019
Device name
SILVERSEAL
Applicant
Noble Fiber Technologies
Decision
Substantially Equivalent
Date received
2004-01-06
Decision date
2004-07-23
Days to decision
199 days
Clearance type
Traditional
Product code
MGQ
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Clarks Summit, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.