The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Drain Sponge.
| Device ID | K991694 |
| 510k Number | K991694 |
| Device Name: | DYNAREX DRAIN SPONGE |
| Classification | Bandage, Liquid |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | John G Moulden |
| Correspondent | John G Moulden DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-18 |
| Decision Date | 1999-07-15 |