FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K Number: K971242
·
Decision Dec 17, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
13
Applicant Total
18
Review Days
259
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Basic Information
- Device Name
- BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
- K Number
- K971242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ipax, Inc.
- Date Received
- April 2, 1997
- Decision Date
- December 17, 1997
- 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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