The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Surgiquest Airseal Ifs.
| Device ID | K132169 |
| 510k Number | K132169 |
| Device Name: | SURGIQUEST AIRSEAL IFS |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-08-22 |
| Summary: | summary |