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FDA 510(k)

AWESMOSIS

K-Number: K945066 · 1995-12-15

Decision Date1995-12-15
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AWESMOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Applied Water Engineering, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K945066. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AWESMOSIS?

AWESMOSIS is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Applied Water Engineering, Inc.. The 510(k) number is K945066.

When did AWESMOSIS receive FDA 510(k) clearance?

AWESMOSIS received FDA 510(k) clearance on 1995-12-15, under 510(k) number K945066.

Who is the listed applicant for AWESMOSIS?

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

What is the FDA product code for AWESMOSIS?

The FDA product code for AWESMOSIS is FIP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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