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FDA 510(k)

PDI PREPMASTER WET PACK MINOR PROCEDURE

K-Number: K840344 · 1984-03-26

ApplicantNice-Pak Products, Inc.
Decision Date1984-03-26
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PDI PREPMASTER WET PACK MINOR PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Nice-Pak Products, Inc.. It received FDA 510(k) clearance on 1984-03-26 under 510(k) number K840344. 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 PDI PREPMASTER WET PACK MINOR PROCEDURE?

PDI PREPMASTER WET PACK MINOR PROCEDURE is a medical device that received FDA 510(k) clearance on 1984-03-26. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K840344.

When did PDI PREPMASTER WET PACK MINOR PROCEDURE receive FDA 510(k) clearance?

PDI PREPMASTER WET PACK MINOR PROCEDURE received FDA 510(k) clearance on 1984-03-26, under 510(k) number K840344.

Who is the listed applicant for PDI PREPMASTER WET PACK MINOR PROCEDURE?

The FDA 510(k) record lists Nice-Pak Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PDI PREPMASTER WET PACK MINOR PROCEDURE?

The FDA product code for PDI PREPMASTER WET PACK MINOR PROCEDURE is FRG.

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Other records listing Nice-Pak Products, 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.

K974768PDI STERILE LUBRICATING JELLYK840343PDI PREPMASTER WET PACK VAGINAL-X21477K840342PDI PREPMASTER WET PACK PATIENT PREP KITK833549PDI SURGICAL SCRUB/BRUSH T150-70K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070K781539ISO-CARE KIT

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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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