510(k) K905433

CODMAN DISPOSABLE SCALP CLIP APPLIER by Codman & Shurtleff, Inc. — Product Code HBO

K905433 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN DISPOSABLE SCALP CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on February 21, 1991. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
December 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Scalp
Device Class
Class II
Regulation Number
882.4150
Review Panel
NE
Submission Type