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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K972824
Device Name THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
Applicant
PN MEDICAL
214 NORTH GOLDENROD RD., #6
ORLANDO,  FL  32807
Applicant Contact PEGGY NICHOLSON
Correspondent
PN MEDICAL
214 NORTH GOLDENROD RD., #6
ORLANDO,  FL  32807
Correspondent Contact PEGGY NICHOLSON
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/30/1997
Decision Date 04/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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