The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Powder.
| Device ID | K834343 |
| 510k Number | K834343 |
| Device Name: | COMFEEL POWDER |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | COLOPLAST A/S 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-12 |
| Decision Date | 1984-11-08 |