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FDA 510(k)

HANDIDAM

K-Number: K884828 · 1989-02-03

ApplicantAseptico, Inc.
Decision Date1989-02-03
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HANDIDAM is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K884828. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDIDAM?

HANDIDAM is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Aseptico, Inc.. The 510(k) number is K884828.

When did HANDIDAM receive FDA 510(k) clearance?

HANDIDAM received FDA 510(k) clearance on 1989-02-03, under 510(k) number K884828.

Who is the listed applicant for HANDIDAM?

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

What is the FDA product code for HANDIDAM?

The FDA product code for HANDIDAM is EIE.

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Other records listing Aseptico, Inc. as applicant

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Related Devices (Code: EIE)

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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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