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 Gown, Isolation, Surgical
510(k) Number K941845
Device Name BUSE STAFF PROTECTION GOWNS AND KITS
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Applicant Contact EILEEN RAMA
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Correspondent Contact EILEEN RAMA
Regulation Number878.4040
Classification Product Code
FYC  
Date Received04/14/1994
Decision Date 05/10/1995
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
-
-