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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K893899
Device Name STERILE LATEX SURGICAL GLOVES
Applicant
LIFE FORCE LABORATORIES, INC.
C/O JAY H. GELLER, LAW OFFICE
11845 WEST OLYMPIC BOULEVARD
LOS ANGELES,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
LIFE FORCE LABORATORIES, INC.
C/O JAY H. GELLER, LAW OFFICE
11845 WEST OLYMPIC BOULEVARD
LOS ANGELES,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/15/1989
Decision Date 09/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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