510(k) K981907
- Device
- V.F.I.-VISCOUS FLUID INFUSION TUBING SET
- Applicant
- PEREGRINE SURGICAL LTD.
- 510(k) number
- K981907
- Product code
- MRH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-04
- Date received
- 1998-06-01
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Ophthalmic
- Medical specialty
- General Hospital
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TODD RICHMOND
- Address
- 4050 D Skyron Dr. Doylestown PA US 18901 18901
FDA Registration Numbers#
- 3007113251
- 3009746061
- 1920664
- 1450662
- 2246552
- 1000125279
- 2183744
- 2029275
- 3010363671
- 3017616393
- 2953359
- 3005641545
- 2183477
- 3004748528
- 1932402
- 1313525
- 3042158861
- 3019924
Source Documents#
Other 510(k) Records For Product Code MRH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243503 | VIA360™ Surgical System | New World Medical, Inc. | 2025-02-14 |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023-08-25 |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | 2022-06-08 |
| K212797 | iPrime Viscodelivery System | Glaukos | 2022-01-06 |
| K211680 | Streamline Surgical System | New World Medical, Inc. | 2021-10-08 |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021-03-01 |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020-08-11 |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017-12-21 |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017-07-27 |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014-12-05 |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | 2013-10-22 |
| K050716 | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | 2005-04-21 |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | 2000-05-08 |
| K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | 2000-01-07 |
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | 1998-02-25 |
Legacy Summary#
summary
FDA Review#
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