FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
K Number: K973697
·
Decision Apr 8, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
3
Review Days
194
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Basic Information
- Device Name
- AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
- K Number
- K973697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Airperm, Inc.
- Date Received
- September 26, 1997
- Decision Date
- April 8, 1998
- Product Code
- MUW
- 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 |
|---|---|---|---|
| MUW | Lens, Contact (Orthokeratology) | FDA class 2 | Ophthalmic |
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