510(k) K874428
K874428 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division Of Tyco Healthc for the device "AUTO SUTURE PURSE STRING APPLIER*". The FDA issued a decision of Substantially Equivalent on Dec 2, 1987. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. United States Surgical, A Division Of Tyco Healthc has 217 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 1987
- Date Received
- Oct 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Clamp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt