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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical
510(k) Number K935391
Device Name SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact JOHN W TOIGO
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact JOHN W TOIGO
Regulation Number878.4820
Classification Product Code
GFA  
Date Received11/08/1993
Decision Date 02/24/1994
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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