The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Regent Biogel Diag Proced Gloves Hypoallerg Claims.
| Device ID | K902601 |
| 510k Number | K902601 |
| Device Name: | REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS |
| Classification | Latex Patient Examination Glove |
| Applicant | REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | H Matelski |
| Correspondent | H Matelski REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-08-10 |