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FDA 510(k)

BIO-SHIELD CSR WRAP

K-Number: K770933 · 1977-09-02

ApplicantConvertors
Decision Date1977-09-02
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIO-SHIELD CSR WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K770933. 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 BIO-SHIELD CSR WRAP?

BIO-SHIELD CSR WRAP is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Convertors. The 510(k) number is K770933.

When did BIO-SHIELD CSR WRAP receive FDA 510(k) clearance?

BIO-SHIELD CSR WRAP received FDA 510(k) clearance on 1977-09-02, under 510(k) number K770933.

Who is the listed applicant for BIO-SHIELD CSR WRAP?

The FDA 510(k) record lists Convertors as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-SHIELD CSR WRAP?

The FDA product code for BIO-SHIELD CSR WRAP is FRG.

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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.

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Other records listing Convertors 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.

K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELSK790234DRAPE PACKS, SURGICAL GOWNSK781959SURGICAL GOWNS, SHEETSK781534SURG-O-PAK PREP PADK781099SURGICAL GOWNS AND DRAPESK780169MASK, SURGICAL

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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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