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FDA 510(k)

PDI PREPMASTER WET PACK VAGINAL-X21477

K-Number: K840343 · 1984-03-27

ApplicantNice-Pak Products, Inc.
Decision Date1984-03-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDI PREPMASTER WET PACK VAGINAL-X21477 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 1984-03-27 under 510(k) number K840343. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDI PREPMASTER WET PACK VAGINAL-X21477?

PDI PREPMASTER WET PACK VAGINAL-X21477 is a medical device that received FDA 510(k) clearance on 1984-03-27. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K840343.

When did PDI PREPMASTER WET PACK VAGINAL-X21477 receive FDA 510(k) clearance?

PDI PREPMASTER WET PACK VAGINAL-X21477 received FDA 510(k) clearance on 1984-03-27, under 510(k) number K840343.

Who is the listed applicant for PDI PREPMASTER WET PACK VAGINAL-X21477?

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 VAGINAL-X21477?

The FDA product code for PDI PREPMASTER WET PACK VAGINAL-X21477 is KGO.

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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 JELLYK840342PDI PREPMASTER WET PACK PATIENT PREP KITK840344PDI PREPMASTER WET PACK MINOR PROCEDUREK833549PDI SURGICAL SCRUB/BRUSH T150-70K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070K781539ISO-CARE KIT

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Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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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