The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Valvotomy Knife.
| Device ID | K843371 |
| 510k Number | K843371 |
| Device Name: | VALVOTOMY KNIFE |
| Classification | Knife, Surgical |
| Applicant | DOWNS SURGICAL LTD. 2500 PARK CENTRAL BLVD Decata , GA 30035 - |
| Contact | Costantino |
| Correspondent | Costantino DOWNS SURGICAL LTD. 2500 PARK CENTRAL BLVD Decata , GA 30035 - |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-10-25 |