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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K910890
Device Name NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
Applicant
Lovell-Schenck, Inc.
1515 Mockingbird Ln.,
Suite 412
Charlotte,  NC  28209
Applicant Contact SUSAN L DEAN
Correspondent
Lovell-Schenck, Inc.
1515 Mockingbird Ln.,
Suite 412
Charlotte,  NC  28209
Correspondent Contact SUSAN L DEAN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received02/19/1991
Decision Date 06/27/1991
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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