The following data is part of a premarket notification filed by Intergrated Visual, Inc. with the FDA for Scalpel Blade Remover (bladegard).
| Device ID | K915119 |
| 510k Number | K915119 |
| Device Name: | SCALPEL BLADE REMOVER (BLADEGARD) |
| Classification | Blade, Scalpel |
| Applicant | INTERGRATED VISUAL, INC. BOATMEN"S BANK BUIDING 6TH & HAMPSHIRE SUITE 609 Quincy, IL 62301 |
| Contact | Richard K.hess |
| Correspondent | Richard K.hess INTERGRATED VISUAL, INC. BOATMEN"S BANK BUIDING 6TH & HAMPSHIRE SUITE 609 Quincy, IL 62301 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-05-05 |