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 K951063
Device Name ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
Applicant
Pymah Corp.
500 Rte. 202 N.
Flemington,  NJ  08822
Applicant Contact GEORGE LEVENDUSKY
Correspondent
Pymah Corp.
500 Rte. 202 N.
Flemington,  NJ  08822
Correspondent Contact GEORGE LEVENDUSKY
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/08/1995
Decision Date 05/10/1995
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
-
-