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FDA 510(k)

SURGICAL GOWNS, EXTRA-LARGE SIZE

K-Number: K910410 · 1991-04-25

ApplicantDawn of Hope Development Center
Decision Date1991-04-25
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWNS, EXTRA-LARGE SIZE is the device name listed in this FDA 510(k) record. The listed applicant is Dawn of Hope Development Center. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K910410. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL GOWNS, EXTRA-LARGE SIZE?

SURGICAL GOWNS, EXTRA-LARGE SIZE is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Dawn of Hope Development Center. The 510(k) number is K910410.

When did SURGICAL GOWNS, EXTRA-LARGE SIZE receive FDA 510(k) clearance?

SURGICAL GOWNS, EXTRA-LARGE SIZE received FDA 510(k) clearance on 1991-04-25, under 510(k) number K910410.

Who is the listed applicant for SURGICAL GOWNS, EXTRA-LARGE SIZE?

The FDA 510(k) record lists Dawn of Hope Development Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL GOWNS, EXTRA-LARGE SIZE?

The FDA product code for SURGICAL GOWNS, EXTRA-LARGE SIZE is FYC.

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Official Source

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