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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K891315
Device Name ATTENUATING SURGICAL GLOVE
Applicant
F & L Medical Products Co.
P.O. Box 165
Leechburg,  PA  15656
Applicant Contact FRED S FOUST
Correspondent
F & L Medical Products Co.
P.O. Box 165
Leechburg,  PA  15656
Correspondent Contact FRED S FOUST
Regulation Number880.6250
Classification Product Code
LZC  
Date Received03/13/1989
Decision Date 10/05/1989
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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