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FDA 510(k)

STANDARD BASIN KIT CUSTOM BASIN KIT

K-Number: K862241 · 1986-08-01

ApplicantQuali-Med, Inc.
Decision Date1986-08-01
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STANDARD BASIN KIT CUSTOM BASIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quali-Med, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862241. 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 STANDARD BASIN KIT CUSTOM BASIN KIT?

STANDARD BASIN KIT CUSTOM BASIN KIT is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Quali-Med, Inc.. The 510(k) number is K862241.

When did STANDARD BASIN KIT CUSTOM BASIN KIT receive FDA 510(k) clearance?

STANDARD BASIN KIT CUSTOM BASIN KIT received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862241.

Who is the listed applicant for STANDARD BASIN KIT CUSTOM BASIN KIT?

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

What is the FDA product code for STANDARD BASIN KIT CUSTOM BASIN KIT?

The FDA product code for STANDARD BASIN KIT CUSTOM BASIN KIT is FRG.

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Other records listing Quali-Med, 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.

K871408BLOOD VESSEL CONNECTORK862972DISPOSABLE MIRRORK862472QUARTZ RODS TITANIUM RODSK862242PAP SMEAR KITK862172QUALI-MED'S OPERATING ROOM DRAPESK861198CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)

View all 7 devices →

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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