510(k) K872532
K872532 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE STAINLESS STEEL SUTURES*". The FDA issued a decision of Substantially Equivalent on August 5, 1987. The device falls under product code GAO (Suture, Nonabsorbable), a Class II device regulated under 21 CFR 878.4495. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1987
- Date Received
- June 26, 1987
- 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