510(k) K932513
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