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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K881413
Device Name ELECTRO-CAUTERY SUCTION TUBE
Applicant
ALTO DEVELOPMENT CORP.
5012 ASBURY RD.
P.O. BOX 758
FARMINGDALE,  NJ  07727
Applicant Contact ALEX WOJCIECHOWICZ
Correspondent
ALTO DEVELOPMENT CORP.
5012 ASBURY RD.
P.O. BOX 758
FARMINGDALE,  NJ  07727
Correspondent Contact ALEX WOJCIECHOWICZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/04/1988
Decision Date 04/21/1988
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
Recalls CDRH Recalls
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