REXAM FRACTURE RESISTANT POUCH— 510(k) K973440

Name: FDA 510(k) clearance K973440
Creator: U.S. Food and Drug Administration
Published: 1997-10-20

Substantially Equivalent

Rexam Medical Packaging, Inc.

FDA 510(k) clearance K973440 for REXAM FRACTURE RESISTANT POUCH, Substantially Equivalent on 1997-10-20. Applicant: Rexam Medical Packaging, Inc.. Device class: 2.

Clearance details

Applicant: Rexam Medical Packaging, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1997-09-10
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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