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FDA 510(k)

ARJOWRAP 47/100 AND 47/88

K-Number: K062100 · 2006-12-05

ApplicantArjo Wiggins Medical, Inc.
Decision Date2006-12-05
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARJOWRAP 47/100 AND 47/88 is the device name listed in this FDA 510(k) record. The listed applicant is Arjo Wiggins Medical, Inc.. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K062100. 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 ARJOWRAP 47/100 AND 47/88?

ARJOWRAP 47/100 AND 47/88 is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Arjo Wiggins Medical, Inc.. The 510(k) number is K062100.

When did ARJOWRAP 47/100 AND 47/88 receive FDA 510(k) clearance?

ARJOWRAP 47/100 AND 47/88 received FDA 510(k) clearance on 2006-12-05, under 510(k) number K062100.

Who is the listed applicant for ARJOWRAP 47/100 AND 47/88?

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

What is the FDA product code for ARJOWRAP 47/100 AND 47/88?

The FDA product code for ARJOWRAP 47/100 AND 47/88 is FRG.

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Other records listing Arjo Wiggins Medical, 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.

K110954ARJORAD STERILE WRAPK931202STERILIZATION WRAP-STERISHEET

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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