The following data is part of a premarket notification filed by Links Medical Products, Inc. with the FDA for Manuka Fill Wound Dressing.
| Device ID | K131796 |
| 510k Number | K131796 |
| Device Name: | MANUKA FILL WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Niguel, CA 92677 |
| Contact | James Smith, Ph.d. |
| Correspondent | James Smith, Ph.d. LINKS MEDICAL PRODUCTS, INC. 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 | No |
| Date Received | 2013-06-18 |
| Decision Date | 2014-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851028001107 | K131796 | 000 |
| 00851028001094 | K131796 | 000 |