FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VAN DELLEN HEALON CANNULA
K Number: K873164
·
Decision Sep 4, 1987
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
7
Review Days
24
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Basic Information
- Device Name
- VAN DELLEN HEALON CANNULA
- K Number
- K873164
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Van Dellen, Ltd.
- Date Received
- August 11, 1987
- Decision Date
- September 4, 1987
- Product Code
- HMX
- 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Van Dellen, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K873465 | VAN DELLEN BACTERIA FILTER | Jan 20, 1988 | Substantially Equivalent |
| K873463 | VAN DELLEN ASPIRATING TUBING | Nov 23, 1987 | Substantially Equivalent |
| K873464 | VAN DELLEN CANNULA | Nov 23, 1987 | Substantially Equivalent |
| K873462 | VAN DELLEN ASPIRATOR | Sep 25, 1987 | Substantially Equivalent |
| K873162 | VAN DELLEN RETROBULBAR NEEDLE | Sep 4, 1987 | Substantially Equivalent |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Sep 4, 1987 | Substantially Equivalent |