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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K873991
Device Name LAKE IRRIGATION TRAY
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 Number880.5570
Classification Product Code
FMI  
Date Received10/01/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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