510(k) K972522
- Device
- ML-DISPOSABLE PAK
- Applicant
- MED-LOGICS, INC.
- 510(k) number
- K972522
- Product code
- MSR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-30
- Date received
- 1997-07-07
- 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
- GLENN A DUNKI-JACOBS
- Address
- 27071 Cabot Rd., Suite 127 Laguna Hills CA US 92653 92653
FDA Registration Numbers#
- 1928237
- 2183744
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 |
| 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 |
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