• 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 K972300
Device Name CROSS-CHECKS P
Applicant
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Applicant Contact TOM ROLL
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Correspondent Contact TOM ROLL
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/19/1997
Decision Date 03/25/1998
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
Recalls CDRH Recalls
-
-