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 Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K880943
Device Name MICROLINE CAT #100
Applicant
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Applicant Contact DE LAFORCADE
Correspondent
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Correspondent Contact DE LAFORCADE
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/07/1988
Decision Date 05/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-