FDA.report

510(k) K162600

Device
Jewel Precision Reusable Rigid Sterilization Container System
Applicant
JEWEL PRECISION SHEET METAL & MACHINE, INC.
510(k) number
K162600
Product code
KCT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-09
Date received
2016-09-19
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GARY SCHNEBERGER
Address
200 Commerce Rd. Cedar Park NJ US 07009 07009

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00840314270184gSourceGSOURCE LLC2025-09-22
00840314269645gSourceGSOURCE LLC2024-10-15
00850043393122Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28
00850043393115Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28
00850043393108Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28
00850043393092Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28
00850043393023Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28
00850043393016Jewel PrecisionJewel Precision Sheet Metal & Machining Inc2023-04-28

Legacy Summary

summary

FDA Review

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