FDA 510(k) Application Details - K981643

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K981643
Device Name Sleeve, Limb, Compressible
Applicant R.T. MEDICAL SERVICES, INC.
730 W. PORTAGE TRAIL EXTENSION
AKRON, OH 44313 US
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Contact KAREN L DIEHL
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 05/08/1998
Decision Date 12/14/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K981643


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