The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Scalpel, One-piece, Disposable.
| Device ID | K854857 |
| 510k Number | K854857 |
| Device Name: | SCALPEL, ONE-PIECE, DISPOSABLE |
| Classification | Scalpel, One-piece |
| Applicant | MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Contact | Oscar D Docal |
| Correspondent | Oscar D Docal MEDELEC INTL. CORP. ONE LINCOLN ROAD, SUITE 304 Miami Beach, FL 33139 |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-05 |
| Decision Date | 1985-12-24 |