FDA 510(k)

COMAN(R) CU-11 MODEL NUMBER 82-6634

K-Number: K945585 · 1995-10-26

ApplicantJohnson & Johnson Professionals, Inc.

Decision Date1995-10-26

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

COMAN(R) CU-11 MODEL NUMBER 82-6634 is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1995-10-26 under 510(k) number K945585. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMAN(R) CU-11 MODEL NUMBER 82-6634?

COMAN(R) CU-11 MODEL NUMBER 82-6634 is a medical device that received FDA 510(k) clearance on 1995-10-26. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K945585.

When did COMAN(R) CU-11 MODEL NUMBER 82-6634 receive FDA 510(k) clearance?

COMAN(R) CU-11 MODEL NUMBER 82-6634 received FDA 510(k) clearance on 1995-10-26, under 510(k) number K945585.

Who is the listed applicant for COMAN(R) CU-11 MODEL NUMBER 82-6634?

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

What is the FDA product code for COMAN(R) CU-11 MODEL NUMBER 82-6634?

The FDA product code for COMAN(R) CU-11 MODEL NUMBER 82-6634 is GWM.

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Official Source

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