FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
(MICRO-KERATRON, MICRO DUCT TREPHINE)
K Number: K791763
·
Decision Nov 5, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
6
Review Days
61
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Basic Information
- Device Name
- (MICRO-KERATRON, MICRO DUCT TREPHINE)
- K Number
- K791763
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4070
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Intl. Ophthalmic Industries Corp.
- Date Received
- September 5, 1979
- Decision Date
- November 5, 1979
- Product Code
- HRG
- 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 |
|---|---|---|---|
| HRG | Engine, Trephine, Accessories, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Intl. Ophthalmic Industries Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | Jul 23, 1996 | Substantially Equivalent |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Oct 31, 1989 | Substantially Equivalent |
| K894512 | PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS | Oct 17, 1989 | Substantially Equivalent |
| K894511 | MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT | Oct 17, 1989 | Substantially Equivalent |
| K823088 | ASPITRON | Apr 6, 1983 | Substantially Equivalent |