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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K772358
Device Name ETHYLENE OXIDE STERILI. INDICATOR
Applicant
Bio-Medical Sciences, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bio-Medical Sciences, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/27/1977
Decision Date 01/30/1978
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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