SOLOS EYESITE DRAPES
FDA 510(k) clearance K872620 · decided 1987-07-31
Clearance details
- K-number
- K872620
- Device name
- SOLOS EYESITE DRAPES
- Applicant
- Solos Ophthalmology
- Decision
- Substantially Equivalent
- Date received
- 1987-07-06
- Decision date
- 1987-07-31
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HMT
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (K945738) | Visitec Co. | 1995-02-14 |
| STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (K905460) | Angiosystems, Inc. | 1991-02-06 |
| OPTHA PREP (K871706) | Treace Medical, Inc. | 1987-05-18 |
| SURGICAL DRAPES, OPHTHALMIN (K854613) | Charles Atkins & Co. | 1986-02-13 |
| DRAIN-R-DRAPE(EYE (K831340) | Sur-Tech, Inc. | 1983-06-08 |
| EYE DRAPE (K830822) | CooperVision, Inc. | 1983-04-06 |
Recalls involving this device
No recalls on record reference this clearance.