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FDA 510(k)

TBC TRAUMA SUIT PROTECTIVE GOWN

K-Number: K923162 · 1994-04-04

ApplicantTbc, Inc.
Decision Date1994-04-04
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TBC TRAUMA SUIT PROTECTIVE GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Tbc, Inc.. It received FDA 510(k) clearance on 1994-04-04 under 510(k) number K923162. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBC TRAUMA SUIT PROTECTIVE GOWN?

TBC TRAUMA SUIT PROTECTIVE GOWN is a medical device that received FDA 510(k) clearance on 1994-04-04. The listed applicant is Tbc, Inc.. The 510(k) number is K923162.

When did TBC TRAUMA SUIT PROTECTIVE GOWN receive FDA 510(k) clearance?

TBC TRAUMA SUIT PROTECTIVE GOWN received FDA 510(k) clearance on 1994-04-04, under 510(k) number K923162.

Who is the listed applicant for TBC TRAUMA SUIT PROTECTIVE GOWN?

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

What is the FDA product code for TBC TRAUMA SUIT PROTECTIVE GOWN?

The FDA product code for TBC TRAUMA SUIT PROTECTIVE GOWN is FYC.

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Official Source

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