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FDA 510(k)

SLIVASURE

K-Number: K051409 · 2005-08-08

ApplicantScandinavian Formulas, Inc.
Decision Date2005-08-08
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SLIVASURE is the device name listed in this FDA 510(k) record. The listed applicant is Scandinavian Formulas, Inc.. It received FDA 510(k) clearance on 2005-08-08 under 510(k) number K051409. The device is classified under product code LED. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIVASURE?

SLIVASURE is a medical device that received FDA 510(k) clearance on 2005-08-08. The listed applicant is Scandinavian Formulas, Inc.. The 510(k) number is K051409.

When did SLIVASURE receive FDA 510(k) clearance?

SLIVASURE received FDA 510(k) clearance on 2005-08-08, under 510(k) number K051409.

Who is the listed applicant for SLIVASURE?

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

What is the FDA product code for SLIVASURE?

The FDA product code for SLIVASURE is LED.

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Related Devices (Code: LED)

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.

K023046SST SALIVA SUPPORTING TABLETSSinclair Pharmaceuticals, Ltd.K860795SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.K860316PANOPTIKONCytocolor, Inc.K860321LYSOCOLORCytocolor, Inc.K860319MEGACOLORCytocolor, Inc.K860320GRANULOCOLORCytocolor, 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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