• 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 K881519
Device Name VAC-G (GUILLOTINE VITRECTOR)
Applicant
B&B MEDICAL ASSOC., INC.
4 CANAL ST.
DANVERS,  MA  01923
Applicant Contact ALDEN C BERTRAND
Correspondent
B&B MEDICAL ASSOC., INC.
4 CANAL ST.
DANVERS,  MA  01923
Correspondent Contact ALDEN C BERTRAND
Regulation Number886.4150
Classification Product Code
HQE  
Date Received04/11/1988
Decision Date 09/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-