HMT — Drape, Patient, Ophthalmic Class II
FDA product code HMT covers "Drape, Patient, Ophthalmic", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HMT
- 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 |
|---|---|---|---|
| K945738 | visitec | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | February 14, 1995 |
| K905460 | angiosystems | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | February 6, 1991 |
| K872620 | solos ophthalmology | SOLOS EYESITE DRAPES | July 31, 1987 |
| K871706 | treace medical | OPTHA PREP | May 18, 1987 |
| K854613 | charles atkins and | SURGICAL DRAPES, OPHTHALMIN | February 13, 1986 |
| K831340 | sur-tech | DRAIN-R-DRAPE(EYE | June 8, 1983 |
| K830822 | coopervision | EYE DRAPE | April 6, 1983 |