FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTAC CASE
K Number: K863846
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
2
Review Days
187
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Basic Information
- Device Name
- CONTAC CASE
- K Number
- K863846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- S. M. C. Medi-Tech Corp.
- Date Received
- October 1, 1986
- Decision Date
- April 6, 1987
- 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 S. M. C. Medi-Tech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871130 | CONTACT LENS TWEEZERS | May 12, 1987 | Substantially Equivalent |