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FDA 510(k)

CRACK-IT CHAP SCREEN

K-Number: K874389 · 1989-02-07

ApplicantSakers, Inc.
Decision Date1989-02-07
Product CodeDMN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CRACK-IT CHAP SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Sakers, Inc.. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K874389. The device is classified under product code DMN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRACK-IT CHAP SCREEN?

CRACK-IT CHAP SCREEN is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Sakers, Inc.. The 510(k) number is K874389.

When did CRACK-IT CHAP SCREEN receive FDA 510(k) clearance?

CRACK-IT CHAP SCREEN received FDA 510(k) clearance on 1989-02-07, under 510(k) number K874389.

Who is the listed applicant for CRACK-IT CHAP SCREEN?

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

What is the FDA product code for CRACK-IT CHAP SCREEN?

The FDA product code for CRACK-IT CHAP SCREEN is DMN.

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 Sakers, 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.

K874390CRACK-IT CANNABINOID SCREEN

Related Devices (Code: DMN)

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.

K972618QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)Phamatech

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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