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FDA 510(k) Application Details - K964425
Device Classification Name
Sleeve, Limb, Compressible
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510(K) Number
K964425
Device Name
Sleeve, Limb, Compressible
Applicant
POWELL,GOLDSTEIN,FRAZER & MURPHY
1001 PENNSYLVANIA AVE, N.W.
SIXTH FLOOR
WASINGTON, DC 20004 US
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Contact
WILLIAM H.E. VON OEHSEN
Other 510(k) Applications for this Contact
Regulation Number
870.5800
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Classification Product Code
JOW
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More FDA Info for this Product Code
Date Received
11/05/1996
Decision Date
07/28/1997
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
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