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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Storage Cover
510(k) Number K030684
Device Name SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact FRANK FUCILE
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact FRANK FUCILE
Regulation Number876.1500
Classification Product Code
OCU  
Date Received03/05/2003
Decision Date 06/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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