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, Biological Sterilization Process
510(k) Number K991618
Device Name BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact JOHN D DYCKMAN
Correspondent
Propper Mfg. Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact JOHN D DYCKMAN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/11/1999
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-