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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 K973314
Device Name SPIROSAFE FILTER
Applicant
Micro Direct, Inc.
1485 Lisbon St.
Lewiston,  ME  04240
Applicant Contact DAVID R STASZAK
Correspondent
Micro Direct, Inc.
1485 Lisbon St.
Lewiston,  ME  04240
Correspondent Contact DAVID R STASZAK
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/03/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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