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Jewel Precision Sheet Metal & Machining, Inc.

Cedar Grove, NJ, US

JEWEL PRECISION SHEET METAL & MACHINING, INC. appears in FDA device records in Cedar Grove, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Jewel Precision Sheet Metal & Machining, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041124483004112448JEWEL PRECISION SHEET METAL & MACHINING, INC.200 COMMERCE RD, CEDAR GROVE, NJ 07009 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2033-2025Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.Class IIOpen, Classified
Z-2026-2025Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain