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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K944376
Device Name ORION ALL SILICONE ELASTOMER COATED CATHETER
Applicant
Regulatory & Marketing Services, Inc.
1247 Florida Ave.
Palm Harbor,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Regulatory & Marketing Services, Inc.
1247 Florida Ave.
Palm Harbor,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/07/1994
Decision Date 11/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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