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 Lens, Guide, Intraocular
510(k) Number K840694
Device Name LENS INSERTION GLIDE
Applicant
Innovative Surgical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Innovative Surgical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4300
Classification Product Code
KYB  
Date Received02/16/1984
Decision Date 05/09/1984
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
-
-