The following data is part of a premarket notification filed by Manuka Medical Limited with the FDA for Manukapli Wound Dressing.
| Device ID | K092689 |
| 510k Number | K092689 |
| Device Name: | MANUKAPLI WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MANUKA MEDICAL LIMITED 29442 POINTE ROYALE Laguna Niguel, CA 92677 |
| Contact | James Smith |
| Correspondent | James Smith MANUKA MEDICAL LIMITED 29442 POINTE ROYALE Laguna Niguel, CA 92677 |
| 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 | 2009-09-02 |
| Decision Date | 2010-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060188822387 | K092689 | 000 |
| 05060188822325 | K092689 | 000 |
| 00854056008134 | K092689 | 000 |
| 00854056008011 | K092689 | 000 |
| 00854056008004 | K092689 | 000 |