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FDA 510(k)

SHEATHES, STERILE SHEATHES

K-Number: K925869 · 1994-01-06

ApplicantMayer Laboratories
Decision Date1994-01-06
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHEATHES, STERILE SHEATHES is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K925869. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEATHES, STERILE SHEATHES?

SHEATHES, STERILE SHEATHES is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Mayer Laboratories. The 510(k) number is K925869.

When did SHEATHES, STERILE SHEATHES receive FDA 510(k) clearance?

SHEATHES, STERILE SHEATHES received FDA 510(k) clearance on 1994-01-06, under 510(k) number K925869.

Who is the listed applicant for SHEATHES, STERILE SHEATHES?

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

What is the FDA product code for SHEATHES, STERILE SHEATHES?

The FDA product code for SHEATHES, STERILE SHEATHES is ITX.

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Official Source

View on FDA Database →

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

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