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510(k) K892117

GENTLEHALER(R) by Schering Research — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
March 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

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