FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BINOCULAR LOUPE
K Number: K830878
·
Decision Apr 6, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
2
Applicant Total
21
Review Days
19
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Basic Information
- Device Name
- BINOCULAR LOUPE
- K Number
- K830878
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- March 18, 1983
- Decision Date
- April 6, 1983
- Product Code
- HJH
- 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 |
|---|---|---|---|
| HJH | Loupe, Binocular, Low Power | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HJH), ordered by most recent decision date.
MALIS SURGICAL LOUPES
FDA 510(k)
FDA Class 1
·Ophthalmic
EXETER OPERATING LOUPE
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Almore Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862851 | ALMORE FACE MASK | Aug 12, 1986 | Substantially Equivalent |
| K854692 | MONARCH II BLEACHING INSTRUMENT | May 12, 1986 | Substantially Equivalent |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Mar 25, 1986 | Substantially Equivalent |
| K854691 | DIAMOND BURS-HANDPIECE | Mar 25, 1986 | Substantially Equivalent |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | Mar 12, 1986 | Substantially Equivalent |
| K854702 | PLASTIC MOUNTING RINGS | Mar 6, 1986 | Substantially Equivalent |
| K854701 | RETRACT-A-CORD | Mar 6, 1986 | Substantially Equivalent |
| K854697 | TUBING HANDPIECE REPLACEMENT | Mar 6, 1986 | Substantially Equivalent |
| K854699 | TUBING SYRING | Jan 6, 1986 | Substantially Equivalent |