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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K931037
Device Name WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)
Applicant
Whitmore Ent., Inc.
Rt. 5 Box 369
San Antonio,  TX  78221
Applicant Contact EARL HARMSEN
Correspondent
Whitmore Ent., Inc.
Rt. 5 Box 369
San Antonio,  TX  78221
Correspondent Contact EARL HARMSEN
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received03/01/1993
Decision Date 07/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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