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FDA 510(k)

REXAM FRACTURE RESISTANT POUCH

K-Number: K973440 · 1997-10-20

ApplicantRexam Medical Packaging, Inc.
Decision Date1997-10-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REXAM FRACTURE RESISTANT POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Rexam Medical Packaging, Inc.. It received FDA 510(k) clearance on 1997-10-20 under 510(k) number K973440. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXAM FRACTURE RESISTANT POUCH?

REXAM FRACTURE RESISTANT POUCH is a medical device that received FDA 510(k) clearance on 1997-10-20. The listed applicant is Rexam Medical Packaging, Inc.. The 510(k) number is K973440.

When did REXAM FRACTURE RESISTANT POUCH receive FDA 510(k) clearance?

REXAM FRACTURE RESISTANT POUCH received FDA 510(k) clearance on 1997-10-20, under 510(k) number K973440.

Who is the listed applicant for REXAM FRACTURE RESISTANT POUCH?

The FDA 510(k) record lists Rexam Medical Packaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REXAM FRACTURE RESISTANT POUCH?

The FDA product code for REXAM FRACTURE RESISTANT POUCH is KCT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Rexam Medical Packaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962600REXAM SELF-SEAL TYVEK POUCH

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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