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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K874000
Device Name PRIA-KIT (TM) PRIAPISM KIT S.S.
Applicant
Canton Medical, Inc.
C/O Casner, Edwards & Roseman
30 Frederal St.
Boston,  MA  02110
Applicant Contact MARTIN E GREENBLATT
Correspondent
Canton Medical, Inc.
C/O Casner, Edwards & Roseman
30 Frederal St.
Boston,  MA  02110
Correspondent Contact MARTIN E GREENBLATT
Regulation Number878.4800
Classification Product Code
GAA  
Date Received10/01/1987
Decision Date 12/30/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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