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 Conformer, Ophthalmic, Biological Tissue
510(k) Number K032104
FOIA Releasable 510(k) K032104
Device Name AMNIOLENS
Applicant
Bio-Tissue, Inc.
1301 K St., NW
Washington,  DC  20005
Applicant Contact DAVID J BLOCH
Correspondent
Bio-Tissue, Inc.
1301 K St., NW
Washington,  DC  20005
Correspondent Contact DAVID J BLOCH
Regulation Number886.3130
Classification Product Code
NQB  
Date Received07/08/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-