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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Natural-Absorbable Gelatin Material
510(k) Number K954401
Device Name GASTROTEC
Applicant
PATRICK C. JACOBSSEN
19730 HUNTRS LOOP
FAIRHOPE,  AL  36532
Applicant Contact PATRICK C JACOBSSEN
Correspondent
PATRICK C. JACOBSSEN
19730 HUNTRS LOOP
FAIRHOPE,  AL  36532
Correspondent Contact PATRICK C JACOBSSEN
Classification Product Code
ESI  
Date Received09/20/1995
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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