The following data is part of a premarket notification filed by Markwell Intl., Inc. with the FDA for Markwell Gauze Sponge.
| Device ID | K982260 |
| 510k Number | K982260 |
| Device Name: | MARKWELL GAUZE SPONGE |
| Classification | Counter, Sponge, Surgical |
| Applicant | MARKWELL INTL., INC. 2550 WEST MAIN ST. , SUITE 212 Alhambra, CA 91801 |
| Contact | Sean Wang |
| Correspondent | Sean Wang MARKWELL INTL., INC. 2550 WEST MAIN ST. , SUITE 212 Alhambra, CA 91801 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-08-12 |