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 Implant, Absorbable, (Scleral Buckling Methods)
510(k) Number K875014
Device Name LABTICIAN RETINAL IMPLANTS
Applicant
Labtician Products, Inc.
7701 Holiday Dr.
Sarasota,  FL  34231
Applicant Contact DAVID SCULATI
Correspondent
Labtician Products, Inc.
7701 Holiday Dr.
Sarasota,  FL  34231
Correspondent Contact DAVID SCULATI
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received12/04/1987
Decision Date 02/26/1988
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
-
-