The following data is part of a premarket notification filed by Manuka Health New Zealand Ltd. with the FDA for Wound Dressing With Manuka Honey.
| Device ID | K133729 |
| 510k Number | K133729 |
| Device Name: | WOUND DRESSING WITH MANUKA HONEY |
| Classification | Dressing, Wound, Drug |
| Applicant | MANUKA HEALTH NEW ZEALAND LTD. 1011 U.S. HIGHWAY 22 SUITE 200 Bridgewater, NJ 08807 -2950 |
| Contact | David Bechtel |
| Correspondent | David Bechtel MANUKA HEALTH NEW ZEALAND LTD. 1011 U.S. HIGHWAY 22 SUITE 200 Bridgewater, NJ 08807 -2950 |
| 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 | 2013-12-06 |
| Decision Date | 2015-01-23 |