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 Laser, Ophthalmic
510(k) Number K895196
Device Name MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
Applicant
Nidek, Inc.
Crc Associates
25422 Trabuco Rd.#105-253
El Toro,  CA  92630
Applicant Contact MCCOMB, PH.D.
Correspondent
Nidek, Inc.
Crc Associates
25422 Trabuco Rd.#105-253
El Toro,  CA  92630
Correspondent Contact MCCOMB, PH.D.
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/11/1989
Decision Date 10/16/1989
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
-
-