The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline Pneumoperitoneum Needle.
| Device ID | K111955 |
| 510k Number | K111955 |
| Device Name: | MEDLINE PNEUMOPERITONEUM NEEDLE |
| Classification | Insufflator, Laparoscopic |
| Applicant | MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2011-11-16 |