CATEGORY 6 OPTHALMIC DEVICES
FDA 510(k) clearance K840310 · decided 1984-03-16
Clearance details
- K-number
- K840310
- Device name
- CATEGORY 6 OPTHALMIC DEVICES
- Applicant
- Imm Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-24
- Decision date
- 1984-03-16
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HOB
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EYE SURGERY INSTRUMENT (K840101) | Truline Instruments, Inc. | 1984-03-16 |
| CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC (K780851) | Varian Assoc., Inc. | 1978-06-30 |
Recalls involving this device
No recalls on record reference this clearance.