510(k) K812566
K812566 is an FDA 510(k) premarket notification submitted by Ortho Pared Instruments, Inc. for the device "UNIVERSAL SUTURE PASSER". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code GDL (Needle, Suturing, Reusable), a Class I device regulated under 21 CFR 878.4800. Ortho Pared Instruments, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1981
- Date Received
- September 9, 1981
- 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