The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Digi-injector.
| Device ID | K971067 |
| 510k Number | K971067 |
| Device Name: | DIGI-INJECTOR |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. San Leandro, CA 94577 |
| Contact | Julian Cortella |
| Correspondent | Julian Cortella MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. San Leandro, CA 94577 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-09-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIGI-INJECTOR 74448002 not registered Dead/Abandoned |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC 1993-10-18 |