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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 K821310
Device Name ESPREE' ANESTHESIA BACTERIAL FILTER
Applicant
Esp Plastics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Esp Plastics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/04/1982
Decision Date 06/11/1982
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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