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 Wrap, Sterilization
510(k) Number K851315
Device Name ABCO INSTRUMENT PACKS & TRAYS
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Applicant Contact CHRISTINE NEMETH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Correspondent Contact CHRISTINE NEMETH
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/02/1985
Decision Date 05/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-