Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K971067
Device Name DIGI-INJECTOR
Applicant
Medical Instrument Development Laboratories, Inc.
14477 Catalina St.
San Leandro,  CA  94577
Applicant Contact JULIAN CORTELLA
Correspondent
Medical Instrument Development Laboratories, Inc.
14477 Catalina St.
San Leandro,  CA  94577
Correspondent Contact JULIAN CORTELLA
Regulation Number880.5725
Classification Product Code
MRH  
Date Received03/24/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-