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 Indicator, Physical/Chemical Sterilization Process
510(k) Number K973585
Device Name PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
Applicant
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact FRANK E PLATKO
Correspondent
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact FRANK E PLATKO
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/22/1997
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-