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 Probe, Lachrymal
510(k) Number K843491
Device Name CONCEPT FIBER OPTIC CANALICULUS INTUBA
Applicant
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Applicant Contact unknown unknown
Correspondent
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Correspondent Contact unknown unknown
Regulation Number886.4350
Classification Product Code
HNL  
Date Received09/06/1984
Decision Date 10/05/1984
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
-
-