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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 K942273
Device Name ORION SUCTION CATHETER KIT WITH STERILE WATER
Applicant
Regulatory & Marketing Services, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Applicant Contact PATRICK LAMB
Correspondent
Regulatory & Marketing Services, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Correspondent Contact PATRICK LAMB
Regulation Number878.4200
Classification Product Code
GBX  
Date Received05/10/1994
Decision Date 06/02/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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