The following data is part of a premarket notification filed by Artiberia with the FDA for 7-103, 7-104, 7-107 Scalpel Handles, #3 #4 #7.
| Device ID | K851750 |
| 510k Number | K851750 |
| Device Name: | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 |
| Classification | Handle, Scalpel |
| Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Contact | Gil M Sanchez |
| Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
| Product Code | GDZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-06-20 |