The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Infiltube.
| Device ID | K925558 |
| 510k Number | K925558 |
| Device Name: | INFILTUBE |
| Classification | Insufflator, Laparoscopic |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1994-03-04 |