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FDA 510(k)

TOURNIQUET/LATEX TOURNIQUET

K-Number: K830467 · 1983-03-31

ApplicantPrimeline Industries, Inc.
Decision Date1983-03-31
Product CodeGAX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOURNIQUET/LATEX TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Primeline Industries, Inc.. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K830467. The device is classified under product code GAX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOURNIQUET/LATEX TOURNIQUET?

TOURNIQUET/LATEX TOURNIQUET is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Primeline Industries, Inc.. The 510(k) number is K830467.

When did TOURNIQUET/LATEX TOURNIQUET receive FDA 510(k) clearance?

TOURNIQUET/LATEX TOURNIQUET received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830467.

Who is the listed applicant for TOURNIQUET/LATEX TOURNIQUET?

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

What is the FDA product code for TOURNIQUET/LATEX TOURNIQUET?

The FDA product code for TOURNIQUET/LATEX TOURNIQUET is GAX.

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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Related Devices (Code: GAX)

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.

K931198UNIQUETIcat SystemsK881398TOURNIQUETBarretta Products, Research and Development, Inc.K881176STERILE ESMARCH BANDAGESpectrum/Hydro-Med Products, Inc.K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.K873928UNIVERSAL TOURNIQUETDryden Corp.K872003KINDERWRAPThe Kinder Co.

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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