FDA 510(k)

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

K-Number: K931874 · 1994-06-10

Decision Date1994-06-10

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Sterile Recoveries, Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K931874. 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 RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE?

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Amsco Sterile Recoveries, Inc.. The 510(k) number is K931874.

When did RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE receive FDA 510(k) clearance?

RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE received FDA 510(k) clearance on 1994-06-10, under 510(k) number K931874.

Who is the listed applicant for RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE?

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

What is the FDA product code for RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE?

The FDA product code for RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE is FRG.

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Other records listing Amsco Sterile Recoveries, Inc. as applicant

K932522AMSCO STERILE RECOVERIES SURGICAL PACKS K931143AMSCO STERILE RECOVERIES ABSORBENT TOWELS K931146SURGICAL DRAPES, MODIFICATION K931145NON-STERILE ISOLATION GOWN K931144STERILE SURGEON'S GOWN, MODIFICATION K931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

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Related Devices (Code: FRG)

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, LLC K253454HALYARD* 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.