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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K931163
Device Name RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE
Applicant
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact RICHARD T LYKINS
Correspondent
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact RICHARD T LYKINS
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/08/1993
Decision Date 06/23/1993
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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