The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Burnet Laboratoire Pharmaceutique Surgical Gloves.
| Device ID | K882392 |
| 510k Number | K882392 |
| Device Name: | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Contact | Darienne Moyer |
| Correspondent | Darienne Moyer ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-08-26 |