The following data is part of a premarket notification filed by Wonder & Bioenergy Hi-tech America, Inc. with the FDA for Vitop Dressing.
| Device ID | K990974 |
| 510k Number | K990974 |
| Device Name: | VITOP DRESSING |
| Classification | Gauze/sponge, Internal |
| Applicant | WONDER & BIOENERGY HI-TECH AMERICA, INC. 108 N. YNEZ AVENUE, SUITE 128 Monterey Park, CA 91754 |
| Contact | Arthur King K Ma |
| Correspondent | Arthur King K Ma WONDER & BIOENERGY HI-TECH AMERICA, INC. 108 N. YNEZ AVENUE, SUITE 128 Monterey Park, CA 91754 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 1999-06-09 |