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FDA 510(k) Application Details - K961217
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K961217
Device Name
Mask, Surgical
Applicant
TRANSIDYNE GENERAL CORP.
400 HERALD JOURNAL PARK
SPARTANBURG, SC 29303 US
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Contact
STEVEN W BUTLER
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
03/28/1996
Decision Date
07/25/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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