PNEUMOCLEAR
Insufflator, Laparoscopic
W.O.M. WORLD OF MEDICINE GmbH
The following data is part of a premarket notification filed by W.o.m. World Of Medicine Gmbh with the FDA for Pneumoclear.
Pre-market Notification Details
| Device ID | K201361 |
| 510k Number | K201361 |
| Device Name: | PNEUMOCLEAR |
| Classification | Insufflator, Laparoscopic |
| 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 | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2020-07-29 |
Trademark Results [PNEUMOCLEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PNEUMOCLEAR 87222408 5392653 Live/Registered |
Stryker Corporation 2016-11-01 |
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