The following data is part of a premarket notification filed by Calidad Solutions, Inc. with the FDA for Activon Tulle.
| Device ID | K101118 |
| 510k Number | K101118 |
| Device Name: | ACTIVON TULLE |
| Classification | Dressing, Wound, Drug |
| Applicant | CALIDAD SOLUTIONS, INC. 22433 72 AVENUE S Kent, WA 98032 |
| Contact | John Billings |
| Correspondent | John Billings CALIDAD SOLUTIONS, INC. 22433 72 AVENUE S Kent, WA 98032 |
| 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 | 2010-04-21 |
| Decision Date | 2010-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060031474152 | K101118 | 000 |
| 05060031474107 | K101118 | 000 |