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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Battery-Powered And Accessories
510(k) Number K944062
Device Name LAPRASCOPIC GRASPER
Applicant
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Applicant Contact BRENDA SPARKS
Correspondent
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Correspondent Contact BRENDA SPARKS
Regulation Number876.1500
Classification Product Code
GCS  
Subsequent Product Code
HTD  
Date Received08/19/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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