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FDA 510(k)

GENT-L-KARE LACERATION TRAYS

K-Number: K950850 · 1995-03-14

ApplicantPremium Plastics, Inc.
Decision Date1995-03-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

GENT-L-KARE LACERATION TRAYS 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 1995-03-14 under 510(k) number K950850. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GENT-L-KARE LACERATION TRAYS?

GENT-L-KARE LACERATION TRAYS is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K950850.

When did GENT-L-KARE LACERATION TRAYS receive FDA 510(k) clearance?

GENT-L-KARE LACERATION TRAYS received FDA 510(k) clearance on 1995-03-14, under 510(k) number K950850.

Who is the listed applicant for GENT-L-KARE LACERATION TRAYS?

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 LACERATION TRAYS?

The FDA product code for GENT-L-KARE LACERATION TRAYS is FRG.

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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 TRAYSK943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATERK850285GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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