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FDA 510(k) Application Details - K982258
Device Classification Name
Sizer, Mammary, Breast Implant Volume
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510(K) Number
K982258
Device Name
Sizer, Mammary, Breast Implant Volume
Applicant
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON, MT 59840 US
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Contact
T JAN VARNER
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Regulation Number
000.0000
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Classification Product Code
MRD
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More FDA Info for this Product Code
Date Received
06/26/1998
Decision Date
09/08/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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