DeviceClearance

CENTURION CIRCLAMP— 510(k) K890897

Substantially Equivalent

Tri-State Hospital Supply Corp.

FDA 510(k) clearance K890897 for CENTURION CIRCLAMP, Substantially Equivalent on 1989-03-28. Applicant: Tri-State Hospital Supply Corp.. Device class: 2.

Clearance details

Applicant
Tri-State Hospital Supply Corp.
Product code
Code HFX
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Howell, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HFX

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More clearances from Tri-State Hospital Supply Corp.

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Adverse events under product code HFX

product code HFX
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K890897

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K890897.

Data sourced from openFDA. This site is unofficial and independent of the FDA.