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FDA 510(k)

STERIMED STERIZATION WRAPPER (NON-STERILE)

K-Number: K953678 · 1995-10-02

ApplicantCustomed, Inc.
Decision Date1995-10-02
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIMED STERIZATION WRAPPER (NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1995-10-02 under 510(k) number K953678. 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 STERIMED STERIZATION WRAPPER (NON-STERILE)?

STERIMED STERIZATION WRAPPER (NON-STERILE) is a medical device that received FDA 510(k) clearance on 1995-10-02. The listed applicant is Customed, Inc.. The 510(k) number is K953678.

When did STERIMED STERIZATION WRAPPER (NON-STERILE) receive FDA 510(k) clearance?

STERIMED STERIZATION WRAPPER (NON-STERILE) received FDA 510(k) clearance on 1995-10-02, under 510(k) number K953678.

Who is the listed applicant for STERIMED STERIZATION WRAPPER (NON-STERILE)?

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

What is the FDA product code for STERIMED STERIZATION WRAPPER (NON-STERILE)?

The FDA product code for STERIMED STERIZATION WRAPPER (NON-STERILE) is FRG.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

View all 36 devices →

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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