FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTHALMIC WIPE
K Number: K942897
·
Decision Aug 5, 1994
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
23
Review Days
46
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Basic Information
- Device Name
- OPTHALMIC WIPE
- K Number
- K942897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Date Received
- June 20, 1994
- Decision Date
- August 5, 1994
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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OPTICAL FRAMES
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FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
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| K980849 | SURGIN KIT | Jul 9, 1998 | Substantially Equivalent |
| K954238 | SURGIN GENISIS HANDPIECE | Dec 8, 1995 | Substantially Equivalent |
| K950600 | VACUUM SURGE SUPRESSER | May 10, 1995 | Substantially Equivalent |
| K942945 | CASSETTE SYSTEM FOR STORZ | Dec 5, 1994 | Substantially Equivalent |
| K942944 | IRRIGATION/BIPOLAR SET | Sep 27, 1994 | Substantially Equivalent |