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510(k) K972283

SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT by Sims — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1997
Date Received
June 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Sims

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