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 K852192
Device Name DISPOSABLE STEAM BIOLOGICAL TEST PACK
Applicant
PARKE-DAVIS CO.
870 PARKDALE RD.
ROCHESTER,  MI  48307
Applicant Contact EDWARD F CLEARY
Correspondent
PARKE-DAVIS CO.
870 PARKDALE RD.
ROCHESTER,  MI  48307
Correspondent Contact EDWARD F CLEARY
Regulation Number880.2800
Classification Product Code
FRC  
Date Received05/20/1985
Decision Date 11/01/1985
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
-
-