FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MALIS SURGICAL LOUPES
K Number: K874845
·
Decision Dec 23, 1987
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
2
Applicant Total
27
Review Days
29
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Basic Information
- Device Name
- MALIS SURGICAL LOUPES
- K Number
- K874845
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Valley Forge Scientific Corp.
- Date Received
- November 24, 1987
- Decision Date
- December 23, 1987
- 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.
EXETER OPERATING LOUPE
FDA 510(k)
FDA Class 1
·Ophthalmic
BINOCULAR LOUPE
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Valley Forge Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K050364 | MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM | Mar 9, 2005 | Substantially Equivalent |
| K042604 | VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS | Oct 22, 2004 | Substantially Equivalent |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | Apr 1, 2004 | Substantially Equivalent |
| K033499 | MALIS IRRIGATION MODULE 1000 | Nov 28, 2003 | Substantially Equivalent |
| K982229 | BI-DENT | Aug 13, 1998 | Substantially Equivalent |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | Dec 19, 1997 | Substantially Equivalent |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Aug 26, 1997 | Substantially Equivalent |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | Jan 9, 1997 | Substantially Equivalent |
| K955764 | VALLEY FORGE BIPLOAR LOOP | Mar 1, 1996 | Substantially Equivalent |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | Dec 8, 1995 | Substantially Equivalent |