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FDA 510(k)

GROMAN PREPMASTER

K-Number: K030292 · 2003-04-15

ApplicantGroman, Inc.
Decision Date2003-04-15
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GROMAN PREPMASTER is the device name listed in this FDA 510(k) record. The listed applicant is Groman, Inc.. It received FDA 510(k) clearance on 2003-04-15 under 510(k) number K030292. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GROMAN PREPMASTER?

GROMAN PREPMASTER is a medical device that received FDA 510(k) clearance on 2003-04-15. The listed applicant is Groman, Inc.. The 510(k) number is K030292.

When did GROMAN PREPMASTER receive FDA 510(k) clearance?

GROMAN PREPMASTER received FDA 510(k) clearance on 2003-04-15, under 510(k) number K030292.

Who is the listed applicant for GROMAN PREPMASTER?

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

What is the FDA product code for GROMAN PREPMASTER?

The FDA product code for GROMAN PREPMASTER is KOJ.

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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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