The following data is part of a premarket notification filed by Surgimed Corp. with the FDA for Surgimed - Surgical Blades.
| Device ID | K851157 |
| 510k Number | K851157 |
| Device Name: | SURGIMED - SURGICAL BLADES |
| Classification | Blade, Scalpel |
| Applicant | SURGIMED CORP. ONE OAK BORRK TERRANCE #500 22ND. AT BUTTERFIELD ROAD Oakbrook Terrance, IL 60181 |
| Contact | Parvez Shirzai |
| Correspondent | Parvez Shirzai SURGIMED CORP. ONE OAK BORRK TERRANCE #500 22ND. AT BUTTERFIELD ROAD Oakbrook Terrance, IL 60181 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-04-25 |