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FDA 510(k)

MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15

K-Number: K952232 · 1995-06-26

ApplicantMedrad, Inc.
Decision Date1995-06-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1995-06-26 under 510(k) number K952232. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15?

MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 is a medical device that received FDA 510(k) clearance on 1995-06-26. The listed applicant is Medrad, Inc.. The 510(k) number is K952232.

When did MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 receive FDA 510(k) clearance?

MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 received FDA 510(k) clearance on 1995-06-26, under 510(k) number K952232.

Who is the listed applicant for MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15?

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

What is the FDA product code for MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15?

The FDA product code for MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 is LNH.

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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.

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