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FDA 510(k)

CALGAESEAL MODEL: CAS

K-Number: K101097 · 2010-09-22

ApplicantBz Medical, Inc.
Decision Date2010-09-22
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

CALGAESEAL MODEL: CAS is the device name listed in this FDA 510(k) record. The listed applicant is Bz Medical, Inc.. It received FDA 510(k) clearance on 2010-09-22 under 510(k) number K101097. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALGAESEAL MODEL: CAS?

CALGAESEAL MODEL: CAS is a medical device that received FDA 510(k) clearance on 2010-09-22. The listed applicant is Bz Medical, Inc.. The 510(k) number is K101097.

When did CALGAESEAL MODEL: CAS receive FDA 510(k) clearance?

CALGAESEAL MODEL: CAS received FDA 510(k) clearance on 2010-09-22, under 510(k) number K101097.

Who is the listed applicant for CALGAESEAL MODEL: CAS?

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

What is the FDA product code for CALGAESEAL MODEL: CAS?

The FDA product code for CALGAESEAL MODEL: CAS is QSY.

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Related Devices (Code: QSY)

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Official Source

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