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FDA 510(k)

SECURE-WRAP (TM) STERILIZATION WRAP

K-Number: K971483 · 1997-06-24

ApplicantAmerican Threshold Industries, Inc.
Decision Date1997-06-24
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECURE-WRAP (TM) STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971483. 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 SECURE-WRAP (TM) STERILIZATION WRAP?

SECURE-WRAP (TM) STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K971483.

When did SECURE-WRAP (TM) STERILIZATION WRAP receive FDA 510(k) clearance?

SECURE-WRAP (TM) STERILIZATION WRAP received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971483.

Who is the listed applicant for SECURE-WRAP (TM) STERILIZATION WRAP?

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

What is the FDA product code for SECURE-WRAP (TM) STERILIZATION WRAP?

The FDA product code for SECURE-WRAP (TM) STERILIZATION WRAP is FRG.

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Other records listing American Threshold Industries, 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.

K953878BOUFFANT CAPK953879SURGEON'S CAPK952114KOOL GARD SINGLES GOWNK952115BARRIER GOWN, KOOL-GARD BACKLESS GOWNK952116COVER GOWNK934085MODIFICATION OF SURGICAL EYESHIELD MASK

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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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