510(k) K771448

STERILE SUTURE REMOVAL KIT by Premium Plastics, Inc. — Product Code KDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1977
Date Received
August 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type