The following data is part of a premarket notification filed by Links Medical Products, Inc. with the FDA for Manuka Ig.
| Device ID | K120976 |
| 510k Number | K120976 |
| Device Name: | MANUKA IG |
| Classification | Dressing, Wound, Drug |
| Applicant | LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Niguel, CA 92677 |
| Contact | James Smith |
| Correspondent | James Smith 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 | Yes |
| Date Received | 2012-04-02 |
| Decision Date | 2012-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851028001374 | K120976 | 000 |
| 10851028001350 | K120976 | 000 |
| 10851028001169 | K120976 | 000 |
| 20197344025371 | K120976 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MANUKA IG 85385581 4441560 Live/Registered |
Links Medical Products Inc. 2011-07-31 |