The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Regent Skindende Exam Glove, Regent Biogel D, Regentbiogel Diagnostic (powderfree).
Device ID | K991677 |
510k Number | K991677 |
Device Name: | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) |
Classification | Latex Patient Examination Glove |
Applicant | LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
Contact | Bradley L Pugh |
Correspondent | Bradley L Pugh LONDON INTERNATIONAL GROUP, INC. P.O. BOX 8308 2926 COLUMBIA HIGHWAY Dothan, AL 36304 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-17 |
Decision Date | 2000-04-12 |