FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISINE FOR CONTACTS
K Number: K991620
·
Decision Sep 24, 1999
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
30
Review Days
136
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Basic Information
- Device Name
- VISINE FOR CONTACTS
- K Number
- K991620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pfizer, Inc.
- Date Received
- May 11, 1999
- Decision Date
- September 24, 1999
- 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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