FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE N-PE MICROKERATOME BLADES
K Number: K022205
·
Decision Oct 3, 2002
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
17
Review Days
90
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Basic Information
- Device Name
- DISPOSABLE N-PE MICROKERATOME BLADES
- K Number
- K022205
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oasis Medical, Inc.
- Date Received
- July 5, 2002
- Decision Date
- October 3, 2002
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | Jun 27, 2002 | Substantially Equivalent |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Mar 8, 2001 | Substantially Equivalent |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Sep 21, 2000 | Substantially Equivalent |
| K980437 | SILICONE PUNCTAL PLUG | Apr 30, 1998 | Substantially Equivalent |
| K950798 | POSTERIOR CAPSULE SHIELD | May 22, 1995 | Substantially Equivalent |
| K950241 | OPHTHALMIC SPONGES | Feb 27, 1995 | Substantially Equivalent |