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 Drape, Surgical, Antimicrobial
510(k) Number K800552
Device Name ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
Applicant
Carl Zeiss, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Carl Zeiss, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/10/1980
Decision Date 03/20/1980
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
-
-