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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K953060
Device Name ROSEBUD DISSECTOR
Applicant
Medical Perspectives Corp.
50 Aiken St.
Unit 213
Norwalk,  CT  06851
Applicant Contact DAVID PIERATOS
Correspondent
Medical Perspectives Corp.
50 Aiken St.
Unit 213
Norwalk,  CT  06851
Correspondent Contact DAVID PIERATOS
Regulation Number878.4450
Classification Product Code
GDY  
Date Received06/30/1995
Decision Date 09/14/1995
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
Predetermined Change
Control Plan Authorized		 No
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