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FDA 510(k)

MODEL SD-1 DISINTEGRATOR

K-Number: K802322 · 1980-11-10

ApplicantNorthgate Research, Inc.
Decision Date1980-11-10
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL SD-1 DISINTEGRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Research, Inc.. It received FDA 510(k) clearance on 1980-11-10 under 510(k) number K802322. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL SD-1 DISINTEGRATOR?

MODEL SD-1 DISINTEGRATOR is a medical device that received FDA 510(k) clearance on 1980-11-10. The listed applicant is Northgate Research, Inc.. The 510(k) number is K802322.

When did MODEL SD-1 DISINTEGRATOR receive FDA 510(k) clearance?

MODEL SD-1 DISINTEGRATOR received FDA 510(k) clearance on 1980-11-10, under 510(k) number K802322.

Who is the listed applicant for MODEL SD-1 DISINTEGRATOR?

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

What is the FDA product code for MODEL SD-1 DISINTEGRATOR?

The FDA product code for MODEL SD-1 DISINTEGRATOR is FFK.

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Related Devices (Code: FFK)

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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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