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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 K772070
Device Name VENTILATOR SETUP, VOLUME
Applicant
Inspiron Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Inspiron Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/01/1977
Decision Date 11/15/1977
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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