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FDA 510(k)

DEFEND SELF-SEALING STERILIZATION POUCH

K-Number: K932056 · 1994-07-13

ApplicantCarl Parker Associates, Inc.
Decision Date1994-07-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEFEND SELF-SEALING STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Carl Parker Associates, Inc.. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K932056. 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 DEFEND SELF-SEALING STERILIZATION POUCH?

DEFEND SELF-SEALING STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Carl Parker Associates, Inc.. The 510(k) number is K932056.

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

DEFEND SELF-SEALING STERILIZATION POUCH received FDA 510(k) clearance on 1994-07-13, under 510(k) number K932056.

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

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

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

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

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Other records listing Carl Parker Associates, 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.

K971130DEFEND FLUID RESISTANT PLEATED MASKK962654COMPLEAT SURGICAL MASKK891308STERILE SURGICAL GLOVESK891257DEFEND LATEX EXAMINATION GLOVESK891157DEFEND LATEX EXAMINATION GLOVESK871558DENTAL FACE MASKS, POLYESTER

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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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