PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
FDA 510(k) clearance K830871 · decided 1983-06-02
Clearance details
- K-number
- K830871
- Device name
- PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
- Applicant
- Phakosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-18
- Decision date
- 1983-06-02
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- HOC
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Phakosystems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PART #860070 ULTRAPAK & #860075 ULTRAPAK (K871474) | Medical Technical Products | 1987-08-10 |
Recalls involving this device
No recalls on record reference this clearance.