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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K923027
Device Name NEURAY SURGICAL PATTIES AND STRIPS
Applicant
Martland Healthcare, Inc.
1068 Rt. 85
Waterford,  CT  06385
Applicant Contact JON C MARTINSEN
Correspondent
Martland Healthcare, Inc.
1068 Rt. 85
Waterford,  CT  06385
Correspondent Contact JON C MARTINSEN
Regulation Number882.4700
Classification Product Code
HBA  
Date Received06/23/1992
Decision Date 08/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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