The following data is part of a premarket notification filed by Henke-sass Wolf, Gmbh. with the FDA for Elmed Pneumoperitoneum Needles.
| Device ID | K943624 |
| 510k Number | K943624 |
| Device Name: | ELMED PNEUMOPERITONEUM NEEDLES |
| Classification | Pneumoperitoneum Needle |
| Applicant | HENKE-SASS WOLF, GMBH. POSTFACH 2459 Tuttlingen, DE 78507 |
| Contact | Randal Chinnock |
| Correspondent | Randal Chinnock HENKE-SASS WOLF, GMBH. POSTFACH 2459 Tuttlingen, DE 78507 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-08-10 |