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FDA 510(k) Application Details - K954401
Device Classification Name
Polymer, Natural-Absorbable Gelatin Material
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510(K) Number
K954401
Device Name
Polymer, Natural-Absorbable Gelatin Material
Applicant
PATRICK C. JACOBSSEN
19730 HUNTRS LOOP
FAIRHOPE, AL 36532 US
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Contact
PATRICK C JACOBSSEN
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Regulation Number
000.0000
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Classification Product Code
ESI
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More FDA Info for this Product Code
Date Received
09/20/1995
Decision Date
04/25/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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