The following data is part of a premarket notification filed by Hasting's Biomedical Corp. with the FDA for Dermavblade(tm).
| Device ID | K945430 |
| 510k Number | K945430 |
| Device Name: | DERMAVBLADE(TM) |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | HASTING'S BIOMEDICAL CORP. 2726 CURVED CREEK RD. Quincy, IL 62301 |
| Contact | Robert J Segal |
| Correspondent | Robert J Segal HASTING'S BIOMEDICAL CORP. 2726 CURVED CREEK RD. Quincy, IL 62301 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1994-11-28 |