The following data is part of a premarket notification filed by Firestone Financial Corp. with the FDA for Modern (sterile Surgeon's Gloves).
| Device ID | K892285 |
| 510k Number | K892285 |
| Device Name: | MODERN (STERILE SURGEON'S GLOVES) |
| Classification | Surgeon's Gloves |
| Applicant | FIRESTONE FINANCIAL CORP. 429 MADERA ST. P.O. BOX 370 San Gabriel, CA 91776 |
| Contact | Fritz Hutcheson |
| Correspondent | Fritz Hutcheson FIRESTONE FINANCIAL CORP. 429 MADERA ST. P.O. BOX 370 San Gabriel, CA 91776 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-06 |
| Decision Date | 1989-05-05 |