510(k) K983448
- Device
- ML UNIVERSAL TUBING
- Applicant
- MED-LOGICS, INC.
- 510(k) number
- K983448
- Product code
- MSR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-18
- Date received
- 1998-09-30
- Regulation
- 886.4150
- Classification name
- Tubing, Replacement, Phacofragmentation Unit
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETTY ROSS
- Address
- 30251 Golden Lantern Suite E-207 Laguna Niguel CA US 92677 92677
FDA Registration Numbers#
- 2183744
- 1928237
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MSR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Hurricane Medical | 2000-01-04 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases