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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K922161
Device Name GRICE SOFT TISSUE BIOPSY KIT
Applicant
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact LORNA K LINVILLE
Correspondent
Ideal Medical, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact LORNA K LINVILLE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/07/1992
Decision Date 10/13/1992
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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