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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, laparoscopic
510(k) Number K930767
Device Name INSUFO-GARD #100-104
Applicant
ACORN MEDICAL, INC.
334 EAST CENTER ST.
NAZARETH,  PA  18064
Applicant Contact KARL BENNETT
Correspondent
ACORN MEDICAL, INC.
334 EAST CENTER ST.
NAZARETH,  PA  18064
Correspondent Contact KARL BENNETT
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/12/1993
Decision Date 04/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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