FDA 510(k)

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

K-Number: K971514 · 1997-10-29

ApplicantLondon International Group, Inc.

Decision Date1997-10-29

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is London International Group, Inc.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K971514. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE?

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is London International Group, Inc.. The 510(k) number is K971514.

When did REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE receive FDA 510(k) clearance?

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE received FDA 510(k) clearance on 1997-10-29, under 510(k) number K971514.

Who is the listed applicant for REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE?

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

What is the FDA product code for REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE?

The FDA product code for REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE is LYY.

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Other records listing London International Group, Inc. as applicant

K991677REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)K984249SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE K980942REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE K980516REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE

Related Devices (Code: LYY)

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Official Source

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