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 Brush, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K780872
FOIA Releasable 510(k) K780872
Device Name CYTOLOGY BRUSH
Applicant
COOPERVISION, INC.
PERMALENS HOUSE
1 BOTLEY ROAD, HEDGE END
SOUTHAMPTON,  GB S033HB
Correspondent
COOPERVISION, INC.
PERMALENS HOUSE
1 BOTLEY ROAD, HEDGE END
SOUTHAMPTON,  GB S033HB
Regulation Number874.4680
Classification Product Code
BTG  
Date Received05/30/1978
Decision Date 09/07/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-