The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Intraducer Peritoneal Catheter 6frx3, 9frx3 1/2, 10frx4, 12frx8.
Device ID | K960883 |
510k Number | K960883 |
Device Name: | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-05 |
Decision Date | 1996-03-20 |