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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 K944412
Device Name THE BREATHER
Applicant
PAL MEDICAL, INC.
2012 1/2 CURRY FORD RD.
ORLANDO,  FL  32806
Applicant Contact PEGGY NICHOLSON
Correspondent
PAL MEDICAL, INC.
2012 1/2 CURRY FORD RD.
ORLANDO,  FL  32806
Correspondent Contact PEGGY NICHOLSON
Regulation Number868.5690
Classification Product Code
BWF  
Date Received09/08/1994
Decision Date 04/26/1995
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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