FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTER-SHARP
K Number: K862070
·
Decision Jun 17, 1986
Classifications
1
FEI Numbers
135
Registration Numbers
136
Same Product Code
2
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- INTER-SHARP
- K Number
- K862070
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Intermedics Intraocular, Inc.
- Date Received
- May 30, 1986
- Decision Date
- June 17, 1986
- Product Code
- HNW
- 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 |
|---|---|---|---|
| HNW | Dilator, Lachrymal | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNW), ordered by most recent decision date.
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