510(k) K770280

CORD, ELECTROSURGICAL-STERILE & DISPOS. by V. Mueller O.V. Baxter Healthcare Corp. — Product Code KNS

K770280 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "CORD, ELECTROSURGICAL-STERILE & DISPOS.". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
February 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type