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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K925382
Device Name CUTTER, SURGICAL
Applicant
Mectra Laboratories, Inc.
Hwy. 231 S.
R.R. #2, Box 376
Bloomfield,  IN  47424
Applicant Contact THOMAS P CLEMENT
Correspondent
Mectra Laboratories, Inc.
Hwy. 231 S.
R.R. #2, Box 376
Bloomfield,  IN  47424
Correspondent Contact THOMAS P CLEMENT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/23/1992
Decision Date 09/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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