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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K882285
Device Name NONREBREATHING CIRCUIT
Applicant
DRYDEN CORP.
10640 EAST 59TH ST.
P.O. BOX 36038
INDIANAPOLIS,  IN  46236
Applicant Contact PAUL E DRYDEN
Correspondent
DRYDEN CORP.
10640 EAST 59TH ST.
P.O. BOX 36038
INDIANAPOLIS,  IN  46236
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/01/1988
Decision Date 08/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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