The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Xeroform Petrolatum Dressing.
| Device ID | K152970 |
| 510k Number | K152970 |
| Device Name: | Dynarex Xeroform Petrolatum Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW STREET Orangeburg, NY 10962 |
| Contact | James Hurlman |
| Correspondent | James Hurlman DYNAREX CORPORATION 10 GLENSHAW STREET Orangeburg, NY 10962 |
| 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 | 2015-10-08 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840117324244 | K152970 | 000 |
| 00616784305417 | K152970 | 000 |
| 00616784305318 | K152970 | 000 |