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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blade, scalpel
510(k) Number K923170
Device Name LOS ALAMOS RETRACTABLE KNIFE
Applicant
INNOVATIVE SURGICAL TECHNOLOGY, INC.
901 18TH ST.
P.O. BOX 148
LOS ALAMOS,  NM  87544
Applicant Contact MICHAEL JACKSON
Correspondent
INNOVATIVE SURGICAL TECHNOLOGY, INC.
901 18TH ST.
P.O. BOX 148
LOS ALAMOS,  NM  87544
Correspondent Contact MICHAEL JACKSON
Regulation Number878.4800
Classification Product Code
GES  
Date Received06/29/1992
Decision Date 02/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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