FDA 510(k)

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

K-Number: K931875 · 1994-06-10

Decision Date1994-06-10

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE 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 K931875. 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 AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE?

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE 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 K931875.

When did AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE receive FDA 510(k) clearance?

AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE received FDA 510(k) clearance on 1994-06-10, under 510(k) number K931875.

Who is the listed applicant for AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE 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 AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE?

The FDA product code for AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE 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 K931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. 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.