AMO PHACOFLEX II INTERSECTION SYSTEM
FDA 510(k) clearance K961242 · decided 1996-06-17
Clearance details
- K-number
- K961242
- Device name
- AMO PHACOFLEX II INTERSECTION SYSTEM
- Applicant
- Allergan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-01
- Decision date
- 1996-06-17
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KYB
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412) | Staar Surgical Co. | 2004-06-10 |
| MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723) | Mastel Precision, Inc. | 2002-12-26 |
| MONARCH II IOL DELIVERY SYSTEM (K001157) | Alcon Research, Ltd. | 2000-06-27 |
| DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129) | Staar Surgical Co. | 1998-12-04 |
| MONARCH IOL DELIVERY SYSTEM (K981571) | Alcon Laboratories | 1998-07-09 |
| MONARCH IOL DELIVERY SYSTEM (K970033) | Alcon Laboratories | 1997-04-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S011) | Allergan, Inc. | 2009-10-02 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S010) | Allergan, Inc. | 2008-01-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S009) | Allergan, Inc. | 2006-09-21 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S006) | Allergan, Inc. | 1997-07-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S005) | Allergan, Inc. | 1996-03-08 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S004) | Allergan, Inc. | 1996-02-01 |
| CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S003) | Allergan, Inc. | 1995-03-03 |
| CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S002) | Allergan, Inc. | 1994-11-23 |