FDA 510(k)

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

K-Number: K101593 · 2010-09-03

ApplicantExact Medical Manufacturing, Inc.

Decision Date2010-09-03

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K101593. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL?

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Exact Medical Manufacturing, Inc.. The 510(k) number is K101593.

When did EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL receive FDA 510(k) clearance?

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL received FDA 510(k) clearance on 2010-09-03, under 510(k) number K101593.

Who is the listed applicant for EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL?

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

What is the FDA product code for EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL?

The FDA product code for EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL is FYA.

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Other records listing Exact Medical Manufacturing, Inc. as applicant

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Related Devices (Code: FYA)

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Official Source

View on FDA Database →

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