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FDA 510(k)

SAFE-T-SEAL

K-Number: K953829 · 1995-11-09

ApplicantGs Medical Packaging, Inc.
Decision Date1995-11-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-T-SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Gs Medical Packaging, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K953829. 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 SAFE-T-SEAL?

SAFE-T-SEAL is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Gs Medical Packaging, Inc.. The 510(k) number is K953829.

When did SAFE-T-SEAL receive FDA 510(k) clearance?

SAFE-T-SEAL received FDA 510(k) clearance on 1995-11-09, under 510(k) number K953829.

Who is the listed applicant for SAFE-T-SEAL?

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

What is the FDA product code for SAFE-T-SEAL?

The FDA product code for SAFE-T-SEAL is KCT.

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

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

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