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 preamplifier, ac-powered, ophthalmic
510(k) Number K924277
Device Name DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
Applicant
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Applicant Contact RICHARD KAISER
Correspondent
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Correspondent Contact RICHARD KAISER
Regulation Number886.1640
Classification Product Code
HLT  
Subsequent Product Code
HLW  
Date Received08/25/1992
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-