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FDA 510(k)

TOSAMA Reusable Applicator

K-Number: K232060 · 2024-04-12

Decision Date2024-04-12
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TOSAMA Reusable Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Tosama, D.O.O.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232060. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOSAMA Reusable Applicator?

TOSAMA Reusable Applicator is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Tosama, D.O.O.. The 510(k) number is K232060.

When did TOSAMA Reusable Applicator receive FDA 510(k) clearance?

TOSAMA Reusable Applicator received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232060.

Who is the listed applicant for TOSAMA Reusable Applicator?

The FDA 510(k) record lists Tosama, D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOSAMA Reusable Applicator?

The FDA product code for TOSAMA Reusable Applicator is HEB.

Other records listing Tosama, D.O.O. 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.

Related Devices (Code: HEB)

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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