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 Suit, Surgical
510(k) Number K891212
Device Name APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE
Applicant
PRO-SAFE PROFESSIONAL LINENS, INC.
304 W. MAIN ST.
GRAND JUNCTION,  CO  81501
Applicant Contact SCOTT KAFKA
Correspondent
PRO-SAFE PROFESSIONAL LINENS, INC.
304 W. MAIN ST.
GRAND JUNCTION,  CO  81501
Correspondent Contact SCOTT KAFKA
Regulation Number878.4040
Classification Product Code
FXO  
Subsequent Product Code
KKX  
Date Received03/07/1989
Decision Date 04/14/1989
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
-
-