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FDA 510(k)

PARAPOST SYSTEM STERILIZABLE ORGANIZER

K-Number: K993835 · 1999-12-16

ApplicantColtene/Whaledent, Inc.
Decision Date1999-12-16
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARAPOST SYSTEM STERILIZABLE ORGANIZER is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1999-12-16 under 510(k) number K993835. 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 PARAPOST SYSTEM STERILIZABLE ORGANIZER?

PARAPOST SYSTEM STERILIZABLE ORGANIZER is a medical device that received FDA 510(k) clearance on 1999-12-16. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K993835.

When did PARAPOST SYSTEM STERILIZABLE ORGANIZER receive FDA 510(k) clearance?

PARAPOST SYSTEM STERILIZABLE ORGANIZER received FDA 510(k) clearance on 1999-12-16, under 510(k) number K993835.

Who is the listed applicant for PARAPOST SYSTEM STERILIZABLE ORGANIZER?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAPOST SYSTEM STERILIZABLE ORGANIZER?

The FDA product code for PARAPOST SYSTEM STERILIZABLE ORGANIZER is FRG.

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Other records listing Coltene/Whaledent, 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.

K071632PERFECT TISSUE CONTOURING SYSTEM IIK051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMK040551COLTOLUX LED CURING LIGHTK033760ONE COAT SE BONDK031752COLTOSOL FK013400SYNERGY FLOW

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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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