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FDA 510(k)

CUSTOM KWIK SET AND/OR PAK

K-Number: K832517 · 1983-10-14

ApplicantNorton Texas Medical Products
Decision Date1983-10-14
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUSTOM KWIK SET AND/OR PAK is the device name listed in this FDA 510(k) record. The listed applicant is Norton Texas Medical Products. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832517. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM KWIK SET AND/OR PAK?

CUSTOM KWIK SET AND/OR PAK is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Norton Texas Medical Products. The 510(k) number is K832517.

When did CUSTOM KWIK SET AND/OR PAK receive FDA 510(k) clearance?

CUSTOM KWIK SET AND/OR PAK received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832517.

Who is the listed applicant for CUSTOM KWIK SET AND/OR PAK?

The FDA 510(k) record lists Norton Texas Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM KWIK SET AND/OR PAK?

The FDA product code for CUSTOM KWIK SET AND/OR PAK is JOL.

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 Norton Texas Medical Products 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.

K843983MYOCARDIAL INSULATORK842194PRESSURE MONITORK842992GRASSHOPPER - RETRACTOR

Related Devices (Code: JOL)

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.

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare CorpK000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories

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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