FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLOS EYESITE DRAPES
K Number: K872620
·
Decision Jul 31, 1987
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
6
Applicant Total
5
Review Days
25
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Basic Information
- Device Name
- SOLOS EYESITE DRAPES
- K Number
- K872620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Solos Ophthalmology
- Date Received
- July 6, 1987
- Decision Date
- July 31, 1987
- Product Code
- HMT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HMT | Drape, Patient, Ophthalmic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMT), ordered by most recent decision date.
VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
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OPTHA PREP
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DRAIN-R-DRAPE(EYE
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EYE DRAPE
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Other Clearances by Solos Ophthalmology
| K Number | Device Name | ||
|---|---|---|---|
| K874334 | SOLOS SINGLE USE TITANIUM TIP | Jan 11, 1988 | Substantially Equivalent |
| K872611 | SOLOS EYESITE CAP SLEEVE | Aug 10, 1987 | Substantially Equivalent |
| K872612 | SOLOS EYESITE SPONGES | Jul 31, 1987 | Substantially Equivalent |
| K872610 | SOLOS EYESITE CANNULAS | Jul 31, 1987 | Substantially Equivalent |