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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Biopsy, Cardiovascular
510(k) Number K882013
Device Name SOFT TISSUE BIOPSY DEVICE
Applicant
OCEAN MEDICAL PRODUCTS, LTD.
2131 MARTINDALE
WYOMING,  MI  49509
Applicant Contact ALAN TAYLOR
Correspondent
OCEAN MEDICAL PRODUCTS, LTD.
2131 MARTINDALE
WYOMING,  MI  49509
Correspondent Contact ALAN TAYLOR
Regulation Number878.4800
Classification Product Code
DWO  
Date Received05/13/1988
Decision Date 06/15/1988
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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