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 unit, cryophthalmic
510(k) Number K940373
Device Name OPHTHALMIC CRYO UNIT
Applicant
DUTCH OPHTHALMIC USA, INC.
TEN MARSHALL RD.
P.O. BOX 968
KINGSTON,  NH  03848
Applicant Contact MARK W FURLONG
Correspondent
DUTCH OPHTHALMIC USA, INC.
TEN MARSHALL RD.
P.O. BOX 968
KINGSTON,  NH  03848
Correspondent Contact MARK W FURLONG
Regulation Number886.4170
Classification Product Code
HPS  
Date Received01/26/1994
Decision Date 07/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-