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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Isometer
510(k) Number K950178
Device Name PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
Applicant
Pharma-Plast Intl. A/S
32 Hemlock St.
Londonderry,  NH  03053 -3730
Applicant Contact WALTER PISKORSKI
Correspondent
Pharma-Plast Intl. A/S
32 Hemlock St.
Londonderry,  NH  03053 -3730
Correspondent Contact WALTER PISKORSKI
Regulation Number888.1520
Classification Product Code
LZE  
Date Received01/17/1995
Decision Date 07/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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