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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 K940156
Device Name THE REEL THING
Applicant
BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE,  CA  92614
Applicant Contact NICK HERBERT
Correspondent
BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE,  CA  92614
Correspondent Contact NICK HERBERT
Regulation Number878.4200
Classification Product Code
GBX  
Date Received01/12/1994
Decision Date 06/07/1994
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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