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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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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