The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Hemostasis Valve And Tubing Set.
| Device ID | K930194 |
| 510k Number | K930194 |
| Device Name: | HEMOSTASIS VALVE AND TUBING SET |
| Classification | Introducer, Catheter |
| Applicant | OPTICON MEDICAL, INC. 806 BRIAN COURT Gurnee, IL 60031 |
| Contact | Jane Patrick |
| Correspondent | Jane Patrick OPTICON MEDICAL, INC. 806 BRIAN COURT Gurnee, IL 60031 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-14 |
| Decision Date | 1993-09-22 |