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510(k) K893213

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1989
Date Received
April 27, 1989
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

Other clearances by Progressive Productions , Ltd.

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