The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Surgiquest Airseal Ifs System.
Device ID | K143404 |
510k Number | K143404 |
Device Name: | SurgiQuest AirSeal IFS System |
Classification | Insufflator, Laparoscopic |
Applicant | SURGIQUEST, INC. 333 Quarry Rd Milford, CT 06460 |
Contact | Daniel Donovan |
Correspondent | Daniel Donovan SURGIQUEST, INC. 333 Quarry Rd Milford, CT 06460 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-28 |
Decision Date | 2015-03-20 |
Summary: | summary |