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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 K932712
Device Name PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
Applicant
PRECISION MED PRODUCTS, LTD.
30 ROBB HILL RD.
SUITE B
MARRTINSVILLE,  IN  46151
Applicant Contact ROD FYE
Correspondent
PRECISION MED PRODUCTS, LTD.
30 ROBB HILL RD.
SUITE B
MARRTINSVILLE,  IN  46151
Correspondent Contact ROD FYE
Regulation Number868.5975
Classification Product Code
BZO  
Date Received06/04/1993
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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