FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONASSE CONTACT LENS CASE
K Number: K991206
·
Decision Jun 6, 2000
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
81
Applicant Total
1
Review Days
424
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Basic Information
- Device Name
- BONASSE CONTACT LENS CASE
- K Number
- K991206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bonasse Ent. Co., Ltd.
- Date Received
- April 9, 1999
- Decision Date
- June 6, 2000
- Product Code
- LRX
- 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 |
|---|---|---|---|
| LRX | Case, Contact Lens | FDA class 2 | Ophthalmic |
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