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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K931176
Device Name BONE SAW BLADES
Applicant
Betzler Mfg., Inc.
12300 Denholm Dr.
P.O. Box 6233
El Monte,  CA  91732
Applicant Contact GREG BETZLER
Correspondent
Betzler Mfg., Inc.
12300 Denholm Dr.
P.O. Box 6233
El Monte,  CA  91732
Correspondent Contact GREG BETZLER
Regulation Number878.4820
Classification Product Code
HWE  
Date Received03/09/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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