The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Wound Exudate Absorber.
| Device ID | K820160 |
| 510k Number | K820160 |
| Device Name: | HOLLISTER WOUND EXUDATE ABSORBER |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | HOLLISTER, INC. 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 | 1982-01-20 |
| Decision Date | 1982-04-21 |