510(k) K780405

INFANT ELECTROSURGICAL GROUNDING PAD by New Dimensions IN Medicine, Inc. — Product Code JOS

K780405 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "INFANT ELECTROSURGICAL GROUNDING PAD". The FDA issued a decision of Substantially Equivalent on April 5, 1978. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. New Dimensions IN Medicine, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type