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FDA 510(k) Application Details - K972185
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K972185
Device Name
Dressing, Wound, Drug
Applicant
STERIPAK, LTD.
GODDARD RD., ASTMOOR
RUNCORN, CHESHIRE WA7 1QF GB
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Contact
JOHN HOLLOWAY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/1997
Decision Date
03/05/1998
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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