The following data is part of a premarket notification filed by Interworld, Inc. with the FDA for Dextranomer.
| Device ID | K872117 |
| 510k Number | K872117 |
| Device Name: | DEXTRANOMER |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | INTERWORLD, INC. 1101 KNOLLWOOD DR. Safety Harbor, FL 34695 -4407 |
| Contact | Ron Theriot |
| Correspondent | Ron Theriot INTERWORLD, INC. 1101 KNOLLWOOD DR. Safety Harbor, FL 34695 -4407 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-07-24 |