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FDA 510(k)

PROTEC-TOP, STERIDENT, BENTO

K-Number: K031022 · 2003-04-14

ApplicantRonpak, Inc.
Decision Date2003-04-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTEC-TOP, STERIDENT, BENTO is the device name listed in this FDA 510(k) record. The listed applicant is Ronpak, Inc.. It received FDA 510(k) clearance on 2003-04-14 under 510(k) number K031022. 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 PROTEC-TOP, STERIDENT, BENTO?

PROTEC-TOP, STERIDENT, BENTO is a medical device that received FDA 510(k) clearance on 2003-04-14. The listed applicant is Ronpak, Inc.. The 510(k) number is K031022.

When did PROTEC-TOP, STERIDENT, BENTO receive FDA 510(k) clearance?

PROTEC-TOP, STERIDENT, BENTO received FDA 510(k) clearance on 2003-04-14, under 510(k) number K031022.

Who is the listed applicant for PROTEC-TOP, STERIDENT, BENTO?

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

What is the FDA product code for PROTEC-TOP, STERIDENT, BENTO?

The FDA product code for PROTEC-TOP, STERIDENT, BENTO is FRG.

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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.

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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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