PART #860070 ULTRAPAK & #860075 ULTRAPAK
FDA 510(k) clearance K871474 · decided 1987-08-10
Clearance details
- K-number
- K871474
- Device name
- PART #860070 ULTRAPAK & #860075 ULTRAPAK
- Applicant
- Medical Technical Products
- Decision
- Substantially Equivalent
- Date received
- 1987-04-14
- Decision date
- 1987-08-10
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- HOC
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, 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 |
|---|---|---|
| PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (K830871) | Phakosystems, Inc. | 1983-06-02 |
Recalls involving this device
No recalls on record reference this clearance.