510(k) K902263
- Device
- OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
- Applicant
- TRIMEDYNE, INC.
- 510(k) number
- K902263
- Product code
- GGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-23
- Date received
- 1990-05-21
- Regulation
- 864.6160
- Classification name
- Pipette, Sahli
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MERRITT M GIRGIS
- Address
- 1311 Valencia Ave. Tustin CA US 92680 92680
FDA Registration Numbers#
- 3010131137
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Catachem, Inc. | 1989-10-12 |
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