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FDA 510(k)

WRAPPEL T

K-Number: K923408 · 1993-04-08

ApplicantStandard Textile Co., Inc.
Decision Date1993-04-08
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WRAPPEL T is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K923408. 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 WRAPPEL T?

WRAPPEL T is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K923408.

When did WRAPPEL T receive FDA 510(k) clearance?

WRAPPEL T received FDA 510(k) clearance on 1993-04-08, under 510(k) number K923408.

Who is the listed applicant for WRAPPEL T?

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

What is the FDA product code for WRAPPEL T?

The FDA product code for WRAPPEL T is FRG.

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Other records listing Standard Textile Co., Inc. as applicant

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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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