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FDA 510(k)

REXAM SELF-SEAL TYVEK POUCH

K-Number: K962600 · 1996-08-09

ApplicantRexam Medical Packaging, Inc.
Decision Date1996-08-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REXAM SELF-SEAL TYVEK 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 1996-08-09 under 510(k) number K962600. 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 SELF-SEAL TYVEK POUCH?

REXAM SELF-SEAL TYVEK POUCH is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Rexam Medical Packaging, Inc.. The 510(k) number is K962600.

When did REXAM SELF-SEAL TYVEK POUCH receive FDA 510(k) clearance?

REXAM SELF-SEAL TYVEK POUCH received FDA 510(k) clearance on 1996-08-09, under 510(k) number K962600.

Who is the listed applicant for REXAM SELF-SEAL TYVEK 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 SELF-SEAL TYVEK POUCH?

The FDA product code for REXAM SELF-SEAL TYVEK 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K973440REXAM FRACTURE RESISTANT 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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