The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Intraducer Port Sc Catalog#31275,31035,30915, And 31450.
| Device ID | K972112 |
| 510k Number | K972112 |
| Device Name: | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 |
| Classification | Catheter, Peritoneal |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT P.O. BOX 326 Geneva, IL 60134 |
| Contact | Glenn Miller |
| Correspondent | Glenn Miller TAUT, INC. 2571 KANEVILLE COURT P.O. BOX 326 Geneva, IL 60134 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1997-12-01 |