The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Lap-pump Pp110.
| Device ID | K163320 |
| 510k Number | K163320 |
| Device Name: | LAP-Pump PP110 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | W.O.M. WORLD OF MEDICINE GMBH SALZUFER 8 Berlin, DE 10587 |
| Contact | Soeren Markworth |
| Correspondent | Soeren Markworth W.O.M. WORLD OF MEDICINE GMBH SALZUFER 8 Berlin, DE 10587 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702001254 | K163320 | 000 |