PROFESSIONAL DISINFECTION SYSTEM (PDS)
FDA 510(k) clearance K863346 · decided 1987-02-27
Clearance details
- K-number
- K863346
- Device name
- PROFESSIONAL DISINFECTION SYSTEM (PDS)
- Applicant
- Ciba Vision Care
- Decision
- Substantially Equivalent
- Date received
- 1986-08-29
- Decision date
- 1987-02-27
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Atlanta, GA, 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 |
|---|---|---|
| AOSEPT DISINFECTANT (P820040/S033) | Ciba Vision Care | 1995-12-13 |
| AOSEPT (R) LENS CUP & AODISC NEUTRALIZER (P820040/S032) | Ciba Vision Care | 1995-10-23 |
| OSEPT(R) & LENSEPT(R) SOLUTIONS (P820040/S030) | Ciba Vision Care | 1994-09-30 |
| CIBATINT(TM) TINTING PROCESS (P820086/S011) | Ciba Vision Care | 1993-11-23 |
| CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS (P810005/S027) | Ciba Vision Care | 1991-12-10 |
| LENSEPT(R) DISINFECTION SYSTEM (P820040/S031) | Ciba Vision Care | 1991-12-10 |
| SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S026) | Ciba Vision Care | 1991-08-08 |
| WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S026) | Ciba Vision Care | 1991-08-06 |