The following data is part of a premarket notification filed by Miltex Instrument Co. with the FDA for Sterile Surgical Blades.
| Device ID | K852141 |
| 510k Number | K852141 |
| Device Name: | STERILE SURGICAL BLADES |
| Classification | Blade, Scalpel |
| Applicant | MILTEX INSTRUMENT CO. 6 OHIO DR. Lake Success, NY 11042 |
| Contact | Klein Kramer |
| Correspondent | Klein Kramer MILTEX INSTRUMENT CO. 6 OHIO DR. Lake Success, NY 11042 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-16 |
| Decision Date | 1985-06-13 |