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FDA 510(k)

AMALGAM DISPENSER

K-Number: K771749 · 1977-09-28

ApplicantNew Dimensions IN Medicine, Inc.
Decision Date1977-09-28
Product CodeEHE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAM DISPENSER is the device name listed in this FDA 510(k) record. The listed applicant is New Dimensions IN Medicine, Inc.. It received FDA 510(k) clearance on 1977-09-28 under 510(k) number K771749. The device is classified under product code EHE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMALGAM DISPENSER?

AMALGAM DISPENSER is a medical device that received FDA 510(k) clearance on 1977-09-28. The listed applicant is New Dimensions IN Medicine, Inc.. The 510(k) number is K771749.

When did AMALGAM DISPENSER receive FDA 510(k) clearance?

AMALGAM DISPENSER received FDA 510(k) clearance on 1977-09-28, under 510(k) number K771749.

Who is the listed applicant for AMALGAM DISPENSER?

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

What is the FDA product code for AMALGAM DISPENSER?

The FDA product code for AMALGAM DISPENSER is EHE.

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 New Dimensions IN Medicine, 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.

K920677CLEARSITE HYDROGEL WOUND DRESSING MODIFICATIONK832145MONOBLOCK PROSTOPERATIVE TENS ELECTRODEK822077RESPIRATION MONITOR TYPE MR-10K780631NDM INFANT ECG PACKPADK780405INFANT ELECTROSURGICAL GROUNDING PAD

Related Devices (Code: EHE)

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.

K771396DISPENSER, MERCURY & TABLET/POWDERJohnson & Johnson Professionals, 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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