Product code MSR
- Device name
- Tubing, Replacement, Phacofragmentation Unit
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4150
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Hurricane Medical | 2000-01-04 |
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | 1998-12-18 |
| K980849 | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | 1998-07-09 |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Storz Instrument Co. | 1998-06-01 |
| K972522 | ML-DISPOSABLE PAK | Med-Logics, Inc. | 1997-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841305111896 | Synergetics | SYNERGETICS USA, INC. | 2018-11-15 |
| 20841305111909 | Synergetics | SYNERGETICS USA, INC. | 2018-11-15 |
| 00757770402083 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770436101 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770431595 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770429394 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770428229 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770428144 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770422159 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770415359 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770414567 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770414130 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770412051 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770411160 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770409549 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770433353 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770431830 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770427130 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770422005 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770417216 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 00757770416127 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-26 |
| 20841305109944 | AGPI | SYNERGETICS USA, INC. | 2016-09-17 |