The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Flu Ven I.v. Set 0153-c Perma-set.
| Device ID | K843692 |
| 510k Number | K843692 |
| Device Name: | FLU VEN I.V. SET 0153-C PERMA-SET |
| Classification | Set, Administration, Intravascular |
| Applicant | VENUSA LTD. 750 THIRD AVENUE 22ND. FLOOR New York , NY 10017 - |
| Contact | Ronald J Guida |
| Correspondent | Ronald J Guida VENUSA LTD. 750 THIRD AVENUE 22ND. FLOOR New York , NY 10017 - |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-19 |
| Decision Date | 1984-10-31 |