ULTRACARE NEUTRALIZING TABLETS
FDA 510(k) clearance K984383 · decided 1998-12-18
Clearance details
- K-number
- K984383
- Device name
- ULTRACARE NEUTRALIZING TABLETS
- Applicant
- Allergan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-08
- Decision date
- 1998-12-18
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- 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.
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 |