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 K781471
Device Name PNEUMATIC VITRECTOMY CONTROL UNIT
Applicant
HELFGOTT MEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HELFGOTT MEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/28/1978
Decision Date 11/08/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-