510(k) K932513

LABELING FOR MYO/WIRE II STERNOTOMY SUTURES by Alto Development Corp. — Product Code GAO

K932513 is an FDA 510(k) premarket notification submitted by Alto Development Corp. for the device "LABELING FOR MYO/WIRE II STERNOTOMY SUTURES". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code GAO (Suture, Nonabsorbable), a Class II device regulated under 21 CFR 878.4495. Alto Development Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
May 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type