FDA 510(k)

IPI LOW PROFILE IMPORT

K-Number: K934796 · 1994-07-14

ApplicantPudenz-Schulte Medical Research Corp.

Decision Date1994-07-14

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IPI LOW PROFILE IMPORT is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1994-07-14 under 510(k) number K934796. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPI LOW PROFILE IMPORT?

IPI LOW PROFILE IMPORT is a medical device that received FDA 510(k) clearance on 1994-07-14. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K934796.

When did IPI LOW PROFILE IMPORT receive FDA 510(k) clearance?

IPI LOW PROFILE IMPORT received FDA 510(k) clearance on 1994-07-14, under 510(k) number K934796.

Who is the listed applicant for IPI LOW PROFILE IMPORT?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPI LOW PROFILE IMPORT?

The FDA product code for IPI LOW PROFILE IMPORT is LJT.

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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.