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FDA 510(k)

ASSURE, SELF-SEALING STERILIZATION POUCH

K-Number: K951590 · 1995-05-17

ApplicantSultan Chemists, Inc.
Decision Date1995-05-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASSURE, SELF-SEALING STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Chemists, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K951590. 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 ASSURE, SELF-SEALING STERILIZATION POUCH?

ASSURE, SELF-SEALING STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Sultan Chemists, Inc.. The 510(k) number is K951590.

When did ASSURE, SELF-SEALING STERILIZATION POUCH receive FDA 510(k) clearance?

ASSURE, SELF-SEALING STERILIZATION POUCH received FDA 510(k) clearance on 1995-05-17, under 510(k) number K951590.

Who is the listed applicant for ASSURE, SELF-SEALING STERILIZATION POUCH?

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

What is the FDA product code for ASSURE, SELF-SEALING STERILIZATION POUCH?

The FDA product code for ASSURE, SELF-SEALING STERILIZATION POUCH is KCT.

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Other records listing Sultan Chemists, 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.

K052699VERSA-LINK PORCELAIN BONDING SYSTEMK052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALK043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALK030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIALK020612SULTAN SPOROX TEST VIAL, MODEL 75195K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

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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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