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 Mask, Surgical
510(k) Number K883658
Device Name I-SPOSE EYE SHIELD
Applicant
Products For Medicine
17853 Santiago #107-347
Villa Park,  CA  92667
Applicant Contact FRED FECHTMAN
Correspondent
Products For Medicine
17853 Santiago #107-347
Villa Park,  CA  92667
Correspondent Contact FRED FECHTMAN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/26/1988
Decision Date 10/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-