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FDA 510(k)

INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17

K-Number: K872607 · 1987-10-05

ApplicantRandolph Engineering, Inc.
Decision Date1987-10-05
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 is the device name listed in this FDA 510(k) record. The listed applicant is Randolph Engineering, Inc.. It received FDA 510(k) clearance on 1987-10-05 under 510(k) number K872607. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17?

INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 is a medical device that received FDA 510(k) clearance on 1987-10-05. The listed applicant is Randolph Engineering, Inc.. The 510(k) number is K872607.

When did INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 receive FDA 510(k) clearance?

INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 received FDA 510(k) clearance on 1987-10-05, under 510(k) number K872607.

Who is the listed applicant for INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17?

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

What is the FDA product code for INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17?

The FDA product code for INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 is HQZ.

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Related Devices (Code: HQZ)

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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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