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FDA 510(k)

MED-TEC TESTICULAR SEPARATOR

K-Number: K951679 · 1995-07-12

ApplicantMedtec, Inc.
Decision Date1995-07-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MED-TEC TESTICULAR SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K951679. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MED-TEC TESTICULAR SEPARATOR?

MED-TEC TESTICULAR SEPARATOR is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Medtec, Inc.. The 510(k) number is K951679.

When did MED-TEC TESTICULAR SEPARATOR receive FDA 510(k) clearance?

MED-TEC TESTICULAR SEPARATOR received FDA 510(k) clearance on 1995-07-12, under 510(k) number K951679.

Who is the listed applicant for MED-TEC TESTICULAR SEPARATOR?

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

What is the FDA product code for MED-TEC TESTICULAR SEPARATOR?

The FDA product code for MED-TEC TESTICULAR SEPARATOR is IYE.

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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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