The following data is part of a premarket notification filed by Links Medical Products, Inc. with the FDA for Manuka Foam Hc, Manuka Foam Hc (with Acrylic Adhesive Border), Manuka Foam Hc (with Silicone Adhesive Border).
| Device ID | K133934 |
| 510k Number | K133934 |
| Device Name: | MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) |
| Classification | Dressing, Wound, Drug |
| Applicant | LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Hills, CA 92677 |
| Contact | James Smith |
| Correspondent | James Smith LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Hills, 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 | 2013-12-23 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851028001404 | K133934 | 000 |