The following data is part of a premarket notification filed by Retro-tech, Llc with the FDA for Retro-tech Dressing.
| Device ID | K060832 |
| 510k Number | K060832 |
| Device Name: | RETRO-TECH DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | RETRO-TECH, LLC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland RETRO-TECH, LLC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| 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 | 2006-03-27 |
| Decision Date | 2007-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00714196941336 | K060832 | 000 |
| 00714196941329 | K060832 | 000 |
| 00714196941312 | K060832 | 000 |
| 00714196941152 | K060832 | 000 |
| 00714196941145 | K060832 | 000 |
| 00714196941138 | K060832 | 000 |
| 00714196941121 | K060832 | 000 |
| 00714196941114 | K060832 | 000 |