The following data is part of a premarket notification filed by Nawa Heilmittel Gmbh with the FDA for Nawalution Skin And Wound Cleanser.
| Device ID | K141660 |
| 510k Number | K141660 |
| Device Name: | NAWALUTION SKIN AND WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | NAWA HEILMITTEL GMBH 700 THIRTEENTH ST, N.W. Washington, DC 20005 |
| Contact | Allyson B Mullen |
| Correspondent | Allyson B Mullen NAWA HEILMITTEL GMBH 700 THIRTEENTH ST, N.W. Washington, DC 20005 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-06-20 |
| Decision Date | 2014-10-31 |
| Summary: | summary |