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FDA 510(k)

SUPERMOUNT

K-Number: K842727 · 1984-08-03

ApplicantE K Ind., Inc.
Decision Date1984-08-03
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SUPERMOUNT is the device name listed in this FDA 510(k) record. The listed applicant is E K Ind., Inc.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K842727. 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 SUPERMOUNT?

SUPERMOUNT is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is E K Ind., Inc.. The 510(k) number is K842727.

When did SUPERMOUNT receive FDA 510(k) clearance?

SUPERMOUNT received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842727.

Who is the listed applicant for SUPERMOUNT?

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

What is the FDA product code for SUPERMOUNT?

The FDA product code for SUPERMOUNT is LED.

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Other records listing E K Ind., 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.

K842931DRABKIN REAGENTK842938ACETIC ACID 1% V/VK842937ACETIC ACID 2% V/VK842935ACETIC ACID, 5% V/VK842936ACETIC ACID, 3% V/VK842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%

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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.

K051409SLIVASUREScandinavian Formulas, Inc.K023046SST SALIVA SUPPORTING TABLETSSinclair Pharmaceuticals, Ltd.K860795SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.K860320GRANULOCOLORCytocolor, Inc.K860321LYSOCOLORCytocolor, Inc.K860319MEGACOLORCytocolor, 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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