The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Adapt Open Access Port, Model 41233.
Device ID | K021731 |
510k Number | K021731 |
Device Name: | ADAPT OPEN ACCESS PORT, MODEL 41233 |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
Contact | Max Cloat |
Correspondent | Max Cloat TAUT, INC. 2571 KANEVILLE COURT 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 | 2002-05-24 |
Decision Date | 2002-08-08 |