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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 K953088
Device Name TRIANGULAR SPONGES
Applicant
MEDICAL PERSPECTIVES CORP.
50 AIKEN ST.
UNIT 213
NORWALK,  CT  06851
Applicant Contact DAVID M PIERATOS
Correspondent
MEDICAL PERSPECTIVES CORP.
50 AIKEN ST.
UNIT 213
NORWALK,  CT  06851
Correspondent Contact DAVID M PIERATOS
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/03/1995
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
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