The following data is part of a premarket notification filed by Taut, Inc. with the FDA for O.p.c. Intravascular Catheter.
| Device ID | K875082 |
| 510k Number | K875082 |
| Device Name: | O.P.C. INTRAVASCULAR CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | R. D Kenseth |
| Correspondent | R. D Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-03-08 |