510(k) K922009

DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 by Remington Medical, Inc. — Product Code DSA

K922009 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101". The FDA issued a decision of Substantially Equivalent on February 25, 1993. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1993
Date Received
April 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type