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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Irrigation
510(k) Number K844922
Device Name PERIMETER THORACIC CATHETER
Applicant
PERIMETER MEDICAL, INC.
2045 NORTH FORBES BLVD.
SUITE 106
TUCSON,  AZ  85745
Applicant Contact GLENN
Correspondent
PERIMETER MEDICAL, INC.
2045 NORTH FORBES BLVD.
SUITE 106
TUCSON,  AZ  85745
Correspondent Contact GLENN
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/19/1984
Decision Date 03/18/1985
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
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