The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Adapt Laparoscopic Port & Adapt Reducer Cap.
Device ID | K010007 |
510k Number | K010007 |
Device Name: | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
Contact | Ronald Kenseth |
Correspondent | Ronald Kenseth 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 | 2001-01-02 |
Decision Date | 2001-02-22 |