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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Intraspinal, Short Term
510(k) Number K930218
Device Name SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
Applicant
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5120
Classification Product Code
MAJ  
Date Received01/15/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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