FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695
K Number: K870278
·
Decision Feb 20, 1987
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
10
Review Days
24
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Basic Information
- Device Name
- CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695
- K Number
- K870278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ryder Intl. Corp.
- Date Received
- January 27, 1987
- Decision Date
- February 20, 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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| K853727 | KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) | Feb 7, 1986 | Substantially Equivalent |
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