FDA 510(k)

EMM EQUIPMENT COVER-POLYTHYLENE

K-Number: K101689 · 2010-09-20

ApplicantExact Medical Manufacturing, Inc.

Decision Date2010-09-20

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EMM EQUIPMENT COVER-POLYTHYLENE 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 2010-09-20 under 510(k) number K101689. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMM EQUIPMENT COVER-POLYTHYLENE?

EMM EQUIPMENT COVER-POLYTHYLENE is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Exact Medical Manufacturing, Inc.. The 510(k) number is K101689.

When did EMM EQUIPMENT COVER-POLYTHYLENE receive FDA 510(k) clearance?

EMM EQUIPMENT COVER-POLYTHYLENE received FDA 510(k) clearance on 2010-09-20, under 510(k) number K101689.

Who is the listed applicant for EMM EQUIPMENT COVER-POLYTHYLENE?

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 EQUIPMENT COVER-POLYTHYLENE?

The FDA product code for EMM EQUIPMENT COVER-POLYTHYLENE is KKX.

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Other records listing Exact Medical Manufacturing, Inc. as applicant

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Related Devices (Code: KKX)

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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.