510(k) K881394
K881394 is an FDA 510(k) premarket notification submitted by China National Medicines C/O Havel'S for the device "NON-STERILE SUTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on April 8, 1988. The device falls under product code GDL (Needle, Suturing, Reusable), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1988
- Date Received
- April 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Suturing, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type