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FDA 510(k)

STERILE, DISP DOME, INDIVID. PKG.

K-Number: K801239 · 1980-07-14

ApplicantPacific Domes, Inc.
Decision Date1980-07-14
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STERILE, DISP DOME, INDIVID. PKG. is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Domes, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801239. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE, DISP DOME, INDIVID. PKG.?

STERILE, DISP DOME, INDIVID. PKG. is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Pacific Domes, Inc.. The 510(k) number is K801239.

When did STERILE, DISP DOME, INDIVID. PKG. receive FDA 510(k) clearance?

STERILE, DISP DOME, INDIVID. PKG. received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801239.

Who is the listed applicant for STERILE, DISP DOME, INDIVID. PKG.?

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

What is the FDA product code for STERILE, DISP DOME, INDIVID. PKG.?

The FDA product code for STERILE, DISP DOME, INDIVID. PKG. is DRS.

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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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