FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARNES-HIND SPECTACLE LENS CLEANER
K Number: K811554
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- BARNES-HIND SPECTACLE LENS CLEANER
- K Number
- K811554
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Barnes-Hind, Inc.
- Date Received
- June 2, 1981
- Decision Date
- July 2, 1981
- Product Code
- HQG
- 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | FDA class 1 | Ophthalmic |
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Other Clearances by Barnes-Hind, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852386 | SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT | Sep 4, 1985 | Substantially Equivalent |
| K812135 | BARNES-HIND WEEKLY CLEANER | Aug 31, 1981 | Substantially Equivalent |
| K810285 | BARNES-HIND ROSE BENGAL OPHTHALMIC STR. | Apr 17, 1981 | Substantially Equivalent |
| K800582 | BARNES-HOND HARD CONTACT LENS STOR. CASE | Mar 25, 1980 | Substantially Equivalent |
| K791901 | BARNES-HIND WETTING & SOAKING SOLUTION | Nov 16, 1979 | Substantially Equivalent |
| K781007 | AUTO-CON | Jun 30, 1978 | Substantially Equivalent |