The following data is part of a premarket notification filed by Anthony N Silvetti, M.d., S.c. with the FDA for Polyglucose Powder.
| Device ID | K884422 |
| 510k Number | K884422 |
| Device Name: | POLYGLUCOSE POWDER |
| Classification | Dressing, Wound, Drug |
| Applicant | ANTHONY N SILVETTI, M.D., S.C. 4660 KENMORE AVE. SUITE 1018 Alexandria, VA 22304 |
| Contact | Kevney J O'connor |
| Correspondent | Kevney J O'connor ANTHONY N SILVETTI, M.D., S.C. 4660 KENMORE AVE. SUITE 1018 Alexandria, VA 22304 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-22 |
| Decision Date | 1989-02-22 |