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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthpiece, breathing
510(k) Number K863049
Device Name INHALATION AID
Applicant
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
90 EAST RIDGE
P.O. BOX 368
RIDGEFIELD,  CT  06877
Applicant Contact RUTH WASSERMAN
Correspondent
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
90 EAST RIDGE
P.O. BOX 368
RIDGEFIELD,  CT  06877
Correspondent Contact RUTH WASSERMAN
Regulation Number868.5620
Classification Product Code
BYP  
Date Received08/12/1986
Decision Date 10/15/1986
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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