FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EYECLOSE EXTERNAL EYELID WEIGHTS
K Number: K940974
·
Decision Jun 8, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
13
Applicant Total
2
Review Days
97
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Basic Information
- Device Name
- EYECLOSE EXTERNAL EYELID WEIGHTS
- K Number
- K940974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meddev Corp.
- Date Received
- March 3, 1994
- Decision Date
- June 8, 1994
- Product Code
- MML
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MML | Weights, Eyelid, External | FDA class 2 | Ophthalmic |
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Other Clearances by Meddev Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Jul 2, 2001 | Substantially Equivalent |