The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Regent Biogel Orthopedic Surgical Glove.
| Device ID | K980516 |
| 510k Number | K980516 |
| Device Name: | REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | LONDON INTERNATIONAL GROUP, INC. 2926 COLUMBIA HIGHWAY P.O. BOX 8308 Dotham, AL 36303 |
| Contact | Neil Anderson, Rac |
| Correspondent | Neil Anderson, Rac LONDON INTERNATIONAL GROUP, INC. 2926 COLUMBIA HIGHWAY P.O. BOX 8308 Dotham, AL 36303 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-10 |
| Decision Date | 1998-04-23 |