510(k) K982379

SUNDT SLIM-LINE ANEURYSM CLIP APPLIER by Johnson & Johnson Professionals, Inc. — Product Code HCI

K982379 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "SUNDT SLIM-LINE ANEURYSM CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1998
Date Received
July 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Aneurysm Clip
Device Class
Class II
Regulation Number
882.4175
Review Panel
NE
Submission Type