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FDA 510(k)

PLEUROFIX THORACENTESIS KIT

K-Number: K820004 · 1982-02-04

ApplicantBurron Medical Products, Inc.
Decision Date1982-02-04
Product CodeGAZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEUROFIX THORACENTESIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820004. The device is classified under product code GAZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUROFIX THORACENTESIS KIT?

PLEUROFIX THORACENTESIS KIT is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K820004.

When did PLEUROFIX THORACENTESIS KIT receive FDA 510(k) clearance?

PLEUROFIX THORACENTESIS KIT received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820004.

Who is the listed applicant for PLEUROFIX THORACENTESIS KIT?

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

What is the FDA product code for PLEUROFIX THORACENTESIS KIT?

The FDA product code for PLEUROFIX THORACENTESIS KIT is GAZ.

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Other records listing Burron Medical Products, 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.

K870403CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTUREK862412INTESTOPLANTK861479CAVAFIX, CENTRAL VENOUS CATHETER KITK860126STIMUPLEX, NERVE STIMULATORK851293IMPLANTOFIXK841428JEJUNOSTOMY SET FOR TUBE FEEDING

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Related Devices (Code: GAZ)

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.

K952605SUCTION/IRRIGATOR TUBING KITSurgical Laser Technologies, Inc.K945978TUBING, NONINVASIVEEndoscopic Technologies, Inc.K930512SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVESCore Dynamics, Inc.K911865NORTEC CONNECTING TUBE SETNorth American Sterilization & Packaging Co.K910471MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBEBaxter Healthcare CorpK910170MAXI-FLOW SUCTION SET 12 FT.Adler Instrument Co.

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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