FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K Number: K000164
·
Decision Jun 2, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
33
Review Days
135
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Basic Information
- Device Name
- COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
- K Number
- K000164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergan, Inc.
- Date Received
- January 19, 2000
- Decision Date
- June 2, 2000
- Product Code
- LPN
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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Other Clearances by Allergan, Inc.
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|---|---|---|---|
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| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Jul 9, 2009 | Substantially Equivalent |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | Sep 14, 2005 | Substantially Equivalent |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 20, 2002 | Substantially Equivalent |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 11, 2002 | Substantially Equivalent |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 21, 2001 | Substantially Equivalent |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Feb 13, 2001 | Substantially Equivalent |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Nov 21, 2000 | Substantially Equivalent |