HMW — Drape, Microscope, Ophthalmic Class II
FDA product code HMW covers "Drape, Microscope, Ophthalmic", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HMW
- Device Class
- Class II
- Regulation Number
- 878.4370
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K911040 | invotec international | INVOTEC MICROSCOPE DRAPE | June 3, 1991 |
| K902763 | north american sterilization and packaging | STERILE INSTRUMENT DRAPE | September 20, 1990 |
| K902851 | medical technique instruments | MICROSCOPE DRAPE | September 10, 1990 |
| K843890 | lifestream int'l | CUSTOM INSTRUMENT DRAPE | October 26, 1984 |