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, Battery-Powered
510(k) Number K952558
Device Name AARON VAC 2
Applicant
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Applicant Contact J. ROBERT SARON
Correspondent
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Correspondent Contact J. ROBERT SARON
Regulation Number886.4150
Classification Product Code
HKP  
Date Received06/02/1995
Decision Date 03/19/1997
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
-
-