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FDA 510(k)

UNI-THANE

K-Number: K831611 · 1983-06-20

ApplicantCarapac Systems, Inc.
Decision Date1983-06-20
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNI-THANE is the device name listed in this FDA 510(k) record. The listed applicant is Carapac Systems, Inc.. It received FDA 510(k) clearance on 1983-06-20 under 510(k) number K831611. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-THANE?

UNI-THANE is a medical device that received FDA 510(k) clearance on 1983-06-20. The listed applicant is Carapac Systems, Inc.. The 510(k) number is K831611.

When did UNI-THANE receive FDA 510(k) clearance?

UNI-THANE received FDA 510(k) clearance on 1983-06-20, under 510(k) number K831611.

Who is the listed applicant for UNI-THANE?

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

What is the FDA product code for UNI-THANE?

The FDA product code for UNI-THANE is NAD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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