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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing and support, ventilator (w harness)
510(k) Number K942572
Device Name VOLUME VENTILATOR
Applicant
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Applicant Contact TERRY G ROSEKOETTER
Correspondent
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact TERRY G ROSEKOETTER
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/31/1994
Decision Date 06/10/1994
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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