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FDA 510(k)

TRACHEOSTOMY CARE TRAY

K-Number: K935685 · 1994-02-10

ApplicantCush Medical Products
Decision Date1994-02-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY CARE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Cush Medical Products. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K935685. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE TRAY?

TRACHEOSTOMY CARE TRAY is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Cush Medical Products. The 510(k) number is K935685.

When did TRACHEOSTOMY CARE TRAY receive FDA 510(k) clearance?

TRACHEOSTOMY CARE TRAY received FDA 510(k) clearance on 1994-02-10, under 510(k) number K935685.

Who is the listed applicant for TRACHEOSTOMY CARE TRAY?

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

What is the FDA product code for TRACHEOSTOMY CARE TRAY?

The FDA product code for TRACHEOSTOMY CARE TRAY is FRG.

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Other records listing Cush 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.

K943424CUSH ISLAND DRESSINGK940518C-SECTION TRAYK941349DENTAL TRAYK941645BIOPSY TRAYK940239EYE TRAYK935684IV START KIT

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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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