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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 K972237
Device Name HAND HELD MEDISPACER
Applicant
THAYER MEDICAL CORP.
4575 SOUTH PALO VERDE RD.,
SUITE 337
TUCSON,  AZ  85714
Applicant Contact JOE LIX
Correspondent
THAYER MEDICAL CORP.
4575 SOUTH PALO VERDE RD.,
SUITE 337
TUCSON,  AZ  85714
Correspondent Contact JOE LIX
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/01/1997
Decision Date 07/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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