FDA 510(k)

STERILE PROTECTIVE SLEEVE W/TOUGH-BORST

K-Number: K822290 · 1982-08-31

ApplicantUniversal Medical Instrument Corp.

Decision Date1982-08-31

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

STERILE PROTECTIVE SLEEVE W/TOUGH-BORST is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1982-08-31 under 510(k) number K822290. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE PROTECTIVE SLEEVE W/TOUGH-BORST?

STERILE PROTECTIVE SLEEVE W/TOUGH-BORST is a medical device that received FDA 510(k) clearance on 1982-08-31. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K822290.

When did STERILE PROTECTIVE SLEEVE W/TOUGH-BORST receive FDA 510(k) clearance?

STERILE PROTECTIVE SLEEVE W/TOUGH-BORST received FDA 510(k) clearance on 1982-08-31, under 510(k) number K822290.

Who is the listed applicant for STERILE PROTECTIVE SLEEVE W/TOUGH-BORST?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE PROTECTIVE SLEEVE W/TOUGH-BORST?

The FDA product code for STERILE PROTECTIVE SLEEVE W/TOUGH-BORST is DQO.

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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.