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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K911785
Device Name RHINO-GUARD
Applicant
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Applicant Contact CURTIS H MILLER
Correspondent
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Correspondent Contact CURTIS H MILLER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/22/1991
Decision Date 10/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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