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 Collagen Corneal Shield
510(k) Number K874224
Device Name BIO-COR II COLLAGEN CORNEAL SHIELD
Applicant
Bausch & Lomb, Inc.
11300 49th St., N.
Clearwater,  FL  34622
Applicant Contact MICHAEL STEVENS
Correspondent
Bausch & Lomb, Inc.
11300 49th St., N.
Clearwater,  FL  34622
Correspondent Contact MICHAEL STEVENS
Regulation Number886.4750
Classification Product Code
MOE  
Date Received10/16/1987
Decision Date 01/22/1988
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
-
-