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FDA 510(k)

ISO-BAC INSTRUMENT WRAP

K-Number: K802919 · 1981-02-02

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1981-02-02
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISO-BAC INSTRUMENT WRAP is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K802919. 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 ISO-BAC INSTRUMENT WRAP?

ISO-BAC INSTRUMENT WRAP is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K802919.

When did ISO-BAC INSTRUMENT WRAP receive FDA 510(k) clearance?

ISO-BAC INSTRUMENT WRAP received FDA 510(k) clearance on 1981-02-02, under 510(k) number K802919.

Who is the listed applicant for ISO-BAC INSTRUMENT WRAP?

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

What is the FDA product code for ISO-BAC INSTRUMENT WRAP?

The FDA product code for ISO-BAC INSTRUMENT WRAP is FRG.

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Other records listing American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK830786DISIMETRIC RELEASE OF INSTRANETICS RADK820994ABSORB FURN SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE II

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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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