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FDA 510(k) Application Details - K962654
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K962654
Device Name
Mask, Surgical
Applicant
CARL PARKER ASSOCIATES, INC.
275 OSER AVE.
HAUPPAUGE, NY 11788 US
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Contact
ANDREW PARKER
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FXX
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More FDA Info for this Product Code
Date Received
07/08/1996
Decision Date
01/27/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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