FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOVEREIGN CATARACT EXTRACTION SYSTEM
K Number: K981116
·
Decision May 19, 1998
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
33
Review Days
53
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Basic Information
- Device Name
- SOVEREIGN CATARACT EXTRACTION SYSTEM
- K Number
- K981116
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergan, Inc.
- Date Received
- March 27, 1998
- Decision Date
- May 19, 1998
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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