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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K931670
Device Name CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
Applicant
CARAPACE, INC.
2701 W CONCORD ST.
BROKEN ARROW,  OK  74012
Applicant Contact JERRY W MYERS
Correspondent
CARAPACE, INC.
2701 W CONCORD ST.
BROKEN ARROW,  OK  74012
Correspondent Contact JERRY W MYERS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/06/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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