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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K925388
Device Name LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER
Applicant
LIFE SHIELD HEALTHCARE PRODUCTS, INC.
15381 STONY CREEK WAY
NOBLESVILLE,  IN  46060
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
LIFE SHIELD HEALTHCARE PRODUCTS, INC.
15381 STONY CREEK WAY
NOBLESVILLE,  IN  46060
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/26/1992
Decision Date 05/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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