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510(k) K853350

SYNCHRONER TM (PROPOSED TRADENAME) by Fisons Corp. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1985
Date Received
August 12, 1985
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

Other clearances by Fisons Corp.

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