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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K932577
Device Name PEDIATRIC GAS SAMPLING
Applicant
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Applicant Contact TERRY ROSENKOETTER
Correspondent
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact TERRY ROSENKOETTER
Regulation Number868.5240
Classification Product Code
CAI  
Date Received05/27/1993
Decision Date 07/22/1993
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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