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FDA 510(k)

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

K-Number: K893135 · 1989-06-22

ApplicantPremium Plastics, Inc.
Decision Date1989-06-22
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K893135. 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 GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER?

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K893135.

When did GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER receive FDA 510(k) clearance?

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER received FDA 510(k) clearance on 1989-06-22, under 510(k) number K893135.

Who is the listed applicant for GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER?

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

What is the FDA product code for GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER?

The FDA product code for GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER is JOL.

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Other records listing Premium Plastics, 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.

K953226PULM O2 SUCTION CATHETER TRAYSK950851GENT-L-KARE TRACHEOSTOMY TRAYSK950850GENT-L-KARE LACERATION TRAYSK943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK850285GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY

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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

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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