FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U.C.E.Z. LENS CLEANER KIT
K Number: K925659
·
Decision Sep 17, 1993
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
26
Applicant Total
44
Review Days
345
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Basic Information
- Device Name
- U.C.E.Z. LENS CLEANER KIT
- K Number
- K925659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Anago, Inc.
- Date Received
- October 7, 1992
- Decision Date
- September 17, 1993
- Product Code
- OCT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCT | Anti Fog Solution And Accessories, Endoscopy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Anago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930161 | ANAGO SPINAL ANESTHESIA TRAY | Jul 6, 1993 | Unknown |
| K926589 | ANAGO WARM PACK | May 26, 1993 | Substantially Equivalent |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | May 26, 1993 | Substantially Equivalent |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | May 26, 1993 | Substantially Equivalent |
| K920615 | ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT | Mar 20, 1993 | Unknown |
| K915415 | GUARDALL SHIELD | Oct 15, 1992 | Substantially Equivalent |
| K913558 | RELIABLE CONE STYLE FACE MASK | Nov 7, 1991 | Substantially Equivalent |
| K905865 | ANTI-FOR SURGICAL FACE MASK | Mar 6, 1991 | Substantially Equivalent |
| K905749 | SURGICAL FACE MASK | Mar 4, 1991 | Substantially Equivalent |
| K904276 | DISPOSABLE BEARD COVER | Nov 21, 1990 | Substantially Equivalent |