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 |