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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osteotome, Manual
510(k) Number K932534
Device Name ISI FENESTRATED DISSECTING AND GRASPING FORCEPS
Applicant
INNOVATIVE SURGICAL, INC.
3071 CONTINENTAL DR.,
SUITE 102
WEST PALM BEACH,  FL  33407
Applicant Contact MARK HAMBLIN
Correspondent
INNOVATIVE SURGICAL, INC.
3071 CONTINENTAL DR.,
SUITE 102
WEST PALM BEACH,  FL  33407
Correspondent Contact MARK HAMBLIN
Regulation Number878.4800
Classification Product Code
GFI  
Date Received05/28/1993
Decision Date 08/19/1993
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
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