The following data is part of a premarket notification filed by Permeaderm, Inc. with the FDA for Permeaderm B, Permeaderm Cw, And Permeaderm Glove.
| Device ID | K153678 |
| 510k Number | K153678 |
| Device Name: | PermeaDerm B, PermeaDerm CW, And PermeaDerm Glove |
| Classification | Dressing, Wound, Drug |
| Applicant | PERMEADERM, INC. 2905 SEGOVIA WAY Carlsbad, CA 92009 |
| Contact | Aubrey Woodroof |
| Correspondent | Aubrey Woodroof PERMEADERM, INC. 2905 SEGOVIA WAY Carlsbad, CA 92009 |
| 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 | 2015-12-21 |
| Decision Date | 2016-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856880007246 | K153678 | 000 |
| 10810125741972 | K153678 | 000 |
| 10810125742009 | K153678 | 000 |
| 10810125742511 | K153678 | 000 |
| 10810125742528 | K153678 | 000 |
| 10810125742535 | K153678 | 000 |
| 10810125742542 | K153678 | 000 |
| 10810125742559 | K153678 | 000 |
| 00856880007321 | K153678 | 000 |
| 00856880007017 | K153678 | 000 |
| 00856880007024 | K153678 | 000 |
| 00856880007031 | K153678 | 000 |
| 00856880007048 | K153678 | 000 |
| 00856880007055 | K153678 | 000 |
| 00856880007215 | K153678 | 000 |
| 00856880007222 | K153678 | 000 |
| 10810125741941 | K153678 | 000 |