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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K961502
Device Name LUBRICATING JELLY, LOW VISCOSITY
Applicant
Span-America Medical Systems, Inc.
70 Commerce Dr.
P.O. Box 5231
Greenville,  SC  29615
Applicant Contact POLLY THOMPSON
Correspondent
Span-America Medical Systems, Inc.
70 Commerce Dr.
P.O. Box 5231
Greenville,  SC  29615
Correspondent Contact POLLY THOMPSON
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received04/19/1996
Decision Date 07/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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