FDA 510(k)

3B FLEX-LITE

K-Number: K103434 · 2011-10-13

Decision Date2011-10-13

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

3B FLEX-LITE is the device name listed in this FDA 510(k) record. The listed applicant is 3B Products, LLC. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K103434. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3B FLEX-LITE?

3B FLEX-LITE is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is 3B Products, LLC. The 510(k) number is K103434.

When did 3B FLEX-LITE receive FDA 510(k) clearance?

3B FLEX-LITE received FDA 510(k) clearance on 2011-10-13, under 510(k) number K103434.

Who is the listed applicant for 3B FLEX-LITE?

The FDA 510(k) record lists 3B Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3B FLEX-LITE?

The FDA product code for 3B FLEX-LITE is BZD.

Other records listing 3B Products, LLC as applicant

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.

K1122713B WILLOW

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Official Source

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