DeviceClearance

Jewel Precision Reusable Rigid Sterilization Container System— 510(k) K162600

Substantially Equivalent

Jewel Precision Sheet Metal & Machine, Inc.

FDA 510(k) clearance K162600 for Jewel Precision Reusable Rigid Sterilization Container System, Substantially Equivalent on 2016-12-09. Applicant: Jewel Precision Sheet Metal & Machine, Inc.. Device class: 2.

Clearance details

Applicant
Jewel Precision Sheet Metal & Machine, Inc.
Product code
Code KCT
Device class
Class 2
Regulation
21 CFR 880.6850
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cedar Park, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KCT

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Recalls naming K162600

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 K162600.

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