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510(k) K984190

BACK-ON-TRAC, MODEL 101BOT by Back-On-Track, Inc. — Product Code HST

K984190 is an FDA 510(k) premarket notification submitted by Back-On-Track, Inc. for the device "BACK-ON-TRAC, MODEL 101BOT". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
November 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

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FDA data resources