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FDA 510(k)

ULTRACAPS S

K-Number: K081273 · 2008-07-10

ApplicantSdi , Ltd.
Decision Date2008-07-10
Product CodeOIV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACAPS S is the device name listed in this FDA 510(k) record. The listed applicant is Sdi , Ltd.. It received FDA 510(k) clearance on 2008-07-10 under 510(k) number K081273. The device is classified under product code OIV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACAPS S?

ULTRACAPS S is a medical device that received FDA 510(k) clearance on 2008-07-10. The listed applicant is Sdi , Ltd.. The 510(k) number is K081273.

When did ULTRACAPS S receive FDA 510(k) clearance?

ULTRACAPS S received FDA 510(k) clearance on 2008-07-10, under 510(k) number K081273.

Who is the listed applicant for ULTRACAPS S?

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

What is the FDA product code for ULTRACAPS S?

The FDA product code for ULTRACAPS S is OIV.

Related Clinical Trials

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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Other records listing Sdi , Ltd. 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.

K073043SET PP

Related Devices (Code: OIV)

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.

K223182Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 AlloyWorldwork S.R.L

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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