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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K931153
Device Name ELPER(TM) BARRIER INTEGRITY MONITORING
Applicant
Igea, S.R.L.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact RODNEY R MUNSEY
Correspondent
Igea, S.R.L.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact RODNEY R MUNSEY
Classification Product Code
LDQ
Date Received03/09/1993
Decision Date 11/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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