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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K894398
Device Name STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE
Applicant
Pymah Corp.
Ati-Division Of Pymah Corp.
11471 Vanowen St.
No. Hollywood,  CA  91605
Applicant Contact ROBERTA PARMELEE
Correspondent
Pymah Corp.
Ati-Division Of Pymah Corp.
11471 Vanowen St.
No. Hollywood,  CA  91605
Correspondent Contact ROBERTA PARMELEE
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/17/1989
Decision Date 09/11/1989
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
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