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 protector, hearing (insert)
510(k) Number K915739
Device Name #903 SILAFLEX II
Applicant
FLENTS PRODUCTS CO., INC.
P.O. BOX 2109
NORWALK,  CT  06852
Applicant Contact PETER C KOHN
Correspondent
FLENTS PRODUCTS CO., INC.
P.O. BOX 2109
NORWALK,  CT  06852
Correspondent Contact PETER C KOHN
Classification Product Code
EWD  
Date Received12/16/1991
Decision Date 06/30/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-