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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K955474
Device Name NEO-PNEUMOCATH
Applicant
INTRA SPECIAL CATHETERS GMBH
1247 FLORIDA AVE.
PALM HABOR,  FL  34683
Applicant Contact PAT LAMB
Correspondent
INTRA SPECIAL CATHETERS GMBH
1247 FLORIDA AVE.
PALM HABOR,  FL  34683
Correspondent Contact PAT LAMB
Regulation Number878.4200
Classification Product Code
GBX  
Date Received11/30/1995
Decision Date 02/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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