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510(k) K902300

EASY BREATHER MODEL 100 ACCESSORIES by Progressive Productions , Ltd. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1990
Date Received
May 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

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