The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Regent Biogel D(tm) Non-sterile Dental Gloves.
| Device ID | K891658 |
| 510k Number | K891658 |
| Device Name: | REGENT BIOGEL D(TM) NON-STERILE DENTAL GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | REGENT HOSPITAL PRODUCTS WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski REGENT HOSPITAL PRODUCTS WASHINGTON SQUARE 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 | 1989-03-20 |
| Decision Date | 1989-06-06 |