Atlas FDA

SHELHIGH BIORING

FDA 510(k) clearance K023940 · decided 2003-06-04

Clearance details

K-number
K023940
Device name
SHELHIGH BIORING
Applicant
Shelhigh, Inc.
Decision
Substantially Equivalent
Date received
2002-11-26
Decision date
2003-06-04
Days to decision
190 days
Clearance type
Traditional
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Union, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.