The following data is part of a premarket notification filed by Miltex Instrument Co. with the FDA for General Surgery Clamp And Needle Holder.
| Device ID | K922659 |
| 510k Number | K922659 |
| Device Name: | GENERAL SURGERY CLAMP AND NEEDLE HOLDER |
| Classification | Clamp, Surgical, General & Plastic Surgery |
| Applicant | MILTEX INSTRUMENT CO. 6 OHIO DR. Lake Success, NY 11042 |
| Contact | Robert B Pugliesi |
| Correspondent | Robert B Pugliesi MILTEX INSTRUMENT CO. 6 OHIO DR. Lake Success, NY 11042 |
| Product Code | GDJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1992-07-21 |