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510(k) K951450

SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY by Strenumed, Inc. — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1995
Date Received
March 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

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