510(k) K790307

FLEXIBLE REAMER, GUIDE WIRE SYSTEM by 3M Company — Product Code HTO

K790307 is an FDA 510(k) premarket notification submitted by 3M Company for the device "FLEXIBLE REAMER, GUIDE WIRE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1979. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. 3M Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1979
Date Received
February 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type