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 K913261
Device Name DWYER EYE SYSTEMS ASPIRATION UNIT
Applicant
SPECTRACARE, INC.
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
SPECTRACARE, INC.
C/O MEDICAL DEVICE CONSULTANTS
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact LYNNE ARONSON
Regulation Number886.4150
Classification Product Code
HQE  
Date Received07/23/1991
Decision Date 01/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-