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 Lenses, Soft Contact, Daily Wear
510(k) Number K942214
Device Name H55 HYDROPHILIC CONTACT LENS
Applicant
Martin S. Knopf Assoc., Inc.
8 Kinkead Dr.
Livingston,  NJ  07039
Applicant Contact MARTIN S KNOPF
Correspondent
Martin S. Knopf Assoc., Inc.
8 Kinkead Dr.
Livingston,  NJ  07039
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/06/1994
Decision Date 07/28/1994
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
-
-