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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K873973
Device Name LAKE WOUND CARE/TREATMENT KIT
Applicant
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Correspondent Contact ELI SCHACHET
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/29/1987
Decision Date 11/20/1987
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
Predetermined Change
Control Plan Authorized		 No
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